NCT01974687

Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

Completed Phase 1, PHASE2 Results posted Last updated 13 September 2018

What this trial tests

Phase 1, PHASE2 trial testing Uprifosbuvir in Chronic Hepatitis C in 178 participants. Completed in 11 September 2015.

Timeline

31 October 2013

Primary endpoint
2 September 2015

11 September 2015

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	178
Start date	31 October 2013
Primary completion	2 September 2015
Estimated completion	11 September 2015

Drugs / interventions tested

• Uprifosbuvir — full drug profile →
• Placebo
• Itraconazole — full drug profile →

Conditions studied

• Chronic Hepatitis C — all drugs for Chronic Hepatitis C →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (AE) Primary · Up to 42 days

An AE was defined as any untoward medical occurrence in a participant administered study drug, and that does not necessarily have a causal relationship with the study drug(s). An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drug(s). The percentage of participants who experienced at least one AE is presented.

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	50.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	33.3
Group A: Uprifosbuvir 50 mg (Cohort 3a)	33.3
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	66.7
Group A: Uprifosbuvir 300 mg (Cohort 5a)	50.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	33.3
Group A: Placebo (Cohort 6a)	50.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	33.3
Group B: Uprifosbuvir 25 mg (Cohort 2b)	66.7
Group B: Uprifosbuvir 50 mg (Cohort 3b)	33.3
Group B: Uprifosbuvir 150 mg (Cohort 4b)	66.7

Percentage of Participants Who Experienced at Least One Treatment-emergent Serious AE (SAE) Primary · Up to 42 days

An SAE was defined as any untoward medical occurrence that at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. The percentage of participants who experienced at least one SAE is presented.

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Percentage of Participants Who Experienced a Treatment-emergent Dose-limiting Toxicity (DLT) Primary · Up to 13 days

A DLT was defined as any of the following events: Any SAE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 confirmed laboratory abnormalities considered by the investigator to be at least reasonably or possibly related to study drug, except for asymptomatic Grade ¾ cholesterol and triglyceride; Any clinical or laboratory AE of any intensity that is considered by the investigator to be at least reasonably or possibly related t

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Percentage of Participants Who Experienced at Least One Treatment-emergent Grade 1, 2, 3, 4 or 5 Laboratory Abnormality Primary · Up to 42 days

Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Treatment-emergent AEs (TEAEs)were graded as: Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. The percentage of participants who experienced at least one Grade 1, 2, 3, 4 or 5 laboratory abnormality is presented.

Grade 1

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	50.00
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	16.7
Group A: Uprifosbuvir 50 mg (Cohort 3a)	16.7
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	50.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	33.3
Group A: Uprifosbuvir 300 mg (Cohort 6a)	33.3
Group A: Placebo (Cohort 6a)	50.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	66.7
Group B: Uprifosbuvir 50 mg (Cohort 3b)	33.3
Group B: Uprifosbuvir 150 mg (Cohort 4b)	66.7

Grade 2

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	16.7
Group A: Uprifosbuvir 50 mg (Cohort 3a)	16.7
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	16.7
Group A: Uprifosbuvir 300 mg (Cohort 5a)	16.7
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Grade 3

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	33.3
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Grade 4

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Grade 5

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Percentage of Participants Who Discontinued Study Drug Due to a Treatment-emergent AE Primary · Up to 14 days

The percentage of participants who discontinued study drug due to an AE is presented.

Group	Value	95% CI
Group A: Placebo (Cohort 1a-Cohort 5a - Pooled)	0.0
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.0
Group A: Uprifosbuvir 150 mg (Cohort 4a) (Fasted and Fed)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 5a)	0.0
Group A: Uprifosbuvir 300 mg (Cohort 6a)	0.0
Group A: Placebo (Cohort 6a)	0.0
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.0
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.0
Group B: Uprifosbuvir 150 mg (Cohort 4b)	0.0

Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A) Primary · Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. All participants were fasted.

Group	Value	95% CI
Group A: Uprifosbuvir 10 mg (Cohort 1a)	0.0410	± 32.7
Group A: Uprifosbuvir 25 mg (Cohort 2a)	0.0837	± 27.9
Group A: Uprifosbuvir 150 mg (Cohort 4a Fasted)	1.67	± 62.7
Group A: Uprifosbuvir 300 mg (Cohort 5a)	2.78	± 37.7
Group A: Uprifosbuvir 50 mg (Cohort 3a)	0.246	± 63.2

AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a) Primary · Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Group	Value	95% CI
Group A: Uprifosbuvir 150 mg (Cohort 4a Fed)	1.05	± 48.5

AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a) Primary · Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Day 1

Group	Value	95% CI
Group A: Uprifosbuvir 300 mg (Cohort 6a)	3.62	± 34.0

Day 7

Group	Value	95% CI
Group A: Uprifosbuvir 300 mg (Cohort 6a)	3.77	± 21.7

AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) Primary · Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Group	Value	95% CI
Group B: Uprifosbuvir 10 mg (Cohort 1b)	0.0640	± 39.8
Group B: Uprifosbuvir 25 mg (Cohort 2b)	0.228	± 49.1
Group B: Uprifosbuvir 50 mg (Cohort 3b)	0.341	± 20.4
Group B: Uprifosbuvir 150 mg (Cohort 4b)	1.17	± NA
Group B: Uprifosbuvir 300 mg (Cohort 5b)	1.39	± 35.4

AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) Primary · Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Day 1

Group	Value	95% CI
Groups C & D: Uprifosbuvir 50 mg (Capsule)	0.394	± 51.4
Groups C & D: Uprifosbuvir 150 mg (Capsule)	1.01	± 52.9
Groups C & D: Uprifosbuvir 300 mg (Capsule)	2.80	± 45.4
Groups C & D: Uprifosbuvir 400 mg (Capsule)	5.54	± 40.1

Day 7

Group	Value	95% CI
Groups C & D: Uprifosbuvir 50 mg (Capsule)	0.347	± 36.2
Groups C & D: Uprifosbuvir 150 mg (Capsule)	0.935	± 36.7
Groups C & D: Uprifosbuvir 300 mg (Capsule)	2.42	± 46.8
Groups C & D: Uprifosbuvir 400 mg (Capsule)	4.59	± 22.1

AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) Primary · Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Day 1

Group	Value	95% CI
Group C: Uprifosbuvir 300 mg (Tablet)	2.00	± 51.7
Group C: Uprifosbuvir 450 mg (Tablet)	3.11	± 45.0

Day 7

Group	Value	95% CI
Group C: Uprifosbuvir 300 mg (Tablet)	1.82	± 43.9
Group C: Uprifosbuvir 450 mg (Tablet)	2.88	± 30.4

AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) Primary · Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose

AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.

Group	Value	95% CI
Group E: Uprifosbuvir 150 mg (Cohort 1e)	1.05	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 42 days (28 days after last study drug administration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A: Placebo (Cohort 1a - Cohort 5a - Pooled)

Serious: 0/10 (0%)

Deaths: —

Group A: Uprifosbuvir 10 mg (Cohort 1a)

Serious: 0/6 (0%)

Deaths: —

Group A: Uprifosbuvir 25 mg (Cohort 2a)

Serious: 0/6 (0%)

Deaths: —

Group A: Uprifosbuvir 50 mg (Cohort 3a)

Serious: 0/6 (0%)

Deaths: —

Group A: Uprifosbuvir 150 mg (Cohort 4a)

Serious: 0/6 (0%)

Deaths: —

Group A: Uprifosbuvir 300 mg (Cohort 5a)

Serious: 0/6 (0%)

Deaths: —

Group A: Placebo (Cohort 6a)

Serious: 0/2 (0%)

Deaths: —

Group A: Uprifosbuvir 300 mg (Cohort 6a)

Serious: 0/6 (0%)

Deaths: —

Group B: Uprifosbuvir 10 mg (Cohort 1b)

Serious: 0/3 (0%)

Deaths: —

Group B: Uprifosbuvir 25 mg (Cohort 2b)

Serious: 0/3 (0%)

Deaths: —

Group B: Uprifosbuvir 50 mg (Cohort 3b)

Serious: 0/3 (0%)

Deaths: —

Group B: Uprifosbuvir 150 mg (Cohort 4b)

Serious: 0/3 (0%)

Deaths: —

Group B: Uprifosbuvir 300 mg (Cohort 5b)

Serious: 0/3 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 50 mg (Capsule)

Serious: 0/11 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 150 mg (Capsule)

Serious: 0/10 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 250 mg (Capsule)

Serious: 0/8 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 300 mg (Capsule)

Serious: 0/18 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 400 mg (Capsule)

Serious: 0/8 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 300 mg (Tablet)

Serious: 0/8 (0%)

Deaths: —

Groups C & D: Uprifosbuvir 450 mg (Tablet)

Serious: 0/8 (0%)

Deaths: —

Groups C & D: Placebo (Pooled)

Serious: 0/9 (0%)

Deaths: —

Group E: Uprifosbuvir 150 mg (Cohort 1e)

Serious: 0/3 (0%)

Deaths: —

Group E: Uprifosbuvir 300 mg (Cohort 2e)

Serious: 0/3 (0%)

Deaths: —

Group E: Uprifosbuvir 450 mg (Cohort 3e)

Serious: 0/8 (0%)

Deaths: —

Group F: Uprifosbuvir 300 mg (Tablet)

Serious: 0/8 (0%)

Deaths: —

Other adverse events (84 terms — click to expand)

Reaction	System	Group A: Placebo (Cohort 1…	Group A: Uprifosbuvir 10 m…	Group A: Uprifosbuvir 25 m…	Group A: Uprifosbuvir 50 m…	Group A: Uprifosbuvir 150 …	Group A: Uprifosbuvir 300 …	Group A: Placebo (Cohort 6a)	Group A: Uprifosbuvir 300 …	Group B: Uprifosbuvir 10 m…	Group B: Uprifosbuvir 25 m…	Group B: Uprifosbuvir 50 m…	Group B: Uprifosbuvir 150 …	Group B: Uprifosbuvir 300 …	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Uprifosbuvir…	Groups C & D: Placebo (Poo…	Group E: Uprifosbuvir 150 …	Group E: Uprifosbuvir 300 …	Group E: Uprifosbuvir 450 …	Group F: Uprifosbuvir 300 …
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abnormal faeces	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ocular hyperaemia	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Visual acuity reduced	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Faeces hard	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia oral	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling cold	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site anaesthesia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site bruise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vessel puncture site reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT01974687 adverse events section.

Sponsor's own description

This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.