NCT00635804 is a Phase 1 clinical trial of MK-3281 in Hepatitis C, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT00635804?

NCT00635804 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00635804?

Interventions in NCT00635804: MK-3281, Placebo to MK-3281.

What condition does NCT00635804 study?

NCT00635804 studies Hepatitis C.

Is NCT00635804 still recruiting?

NCT00635804 is currently completed. Last updated 5 September 2018.

Are results published for NCT00635804?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-05 · How we verify

NCT00635804

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)

Completed Phase 1 Results posted Last updated 5 September 2018

What this trial tests

Phase 1 trial testing MK-3281 in Hepatitis C in 60 participants. Completed in 22 December 2009.

Timeline

19 February 2008

Primary endpoint
22 December 2009

22 December 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	19 February 2008
Primary completion	22 December 2009
Estimated completion	22 December 2009

Drugs / interventions tested

MK-3281 — full drug profile →
Placebo to MK-3281 — full drug profile →

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, male only, with 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.

Number of Participants Experiencing Adverse Events (AEs) Primary · Up to 14 days after the last dose of study drug (up to 24 days maximum)

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	5
Pt 1: MK-3281 200 mg BID (Panel B)	3
Pt 1: MK-3281 400 mg BID (Panel C)	4
Pt 1: MK-3281 800 mg BID (Panel D)	5
Pt 2: MK-3281 800 mg BID (Panel E)	3
Pt 2: MK-3281 800 mg BID (Panel F)	12
Pt 2: MK-3281 1200 mg BID (Panel G)	2
Placebo	12

Number of Participants Who Discontinued Study Medication Due to AEs Primary · Up to 14 days after the last dose of study drug (up to 24 days maximum)

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	0
Pt 1: MK-3281 200 mg BID (Panel B)	0
Pt 1: MK-3281 400 mg BID (Panel C)	0
Pt 1: MK-3281 800 mg BID (Panel D)	0
Pt 2: MK-3281 800 mg BID (Panel E)	0
Pt 2: MK-3281 800 mg BID (Panel F)	1
Pt 2: MK-3281 1200 mg BID (Panel G)	0
Placebo	0

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.

Day 1

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	4.92	± 39.9
Pt 1: MK-3281 200 mg BID (Panel B)	12.39	± 36.2
Pt 1: MK-3281 400 mg BID (Panel C)	13.21	± 45.0
Pt 1: MK-3281 800 mg BID (Panel D)	18.12	± 70.9
Pt 2: MK-3281 800 mg BID (Panel E)	12.78	± 22.4
Pt 2: MK-3281 800 mg BID (Panel F)	11.36	± 47.7
Pt 2: MK-3281 1200 mg BID (Panel G)	12.01	± 27.5

Day 7

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	NA	± NA
Pt 1: MK-3281 200 mg BID (Panel B)	NA	± NA
Pt 1: MK-3281 400 mg BID (Panel C)	NA	± NA
Pt 1: MK-3281 800 mg BID (Panel D)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel E)	61.08	± 20.1
Pt 2: MK-3281 800 mg BID (Panel F)	51.68	± 29.8
Pt 2: MK-3281 1200 mg BID (Panel G)	88.21	± 37.0

Day 10

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	11.51	± 31.7
Pt 1: MK-3281 200 mg BID (Panel B)	29.71	± 32.1
Pt 1: MK-3281 400 mg BID (Panel C)	37.21	± 22.6
Pt 1: MK-3281 800 mg BID (Panel D)	67.11	± 28.1
Pt 2: MK-3281 800 mg BID (Panel E)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel F)	NA	± NA
Pt 2: MK-3281 1200 mg BID (Panel G)	NA	± NA

Maximum Plasma Concentration (Cmax) of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.

Day 1

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	0.74	± 32.6
Pt 1: MK-3281 200 mg BID (Panel B)	1.75	± 39.1
Pt 1: MK-3281 400 mg BID (Panel C)	1.80	± 48.3
Pt 1: MK-3281 800 mg BID (Panel D)	2.73	± 75.9
Pt 2: MK-3281 800 mg BID (Panel E)	1.61	± 24.9
Pt 2: MK-3281 800 mg BID (Panel F)	1.60	± 43.7
Pt 2: MK-3281 1200 mg BID (Panel G)	1.69	± 28.4

Day 7

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	NA	± NA
Pt 1: MK-3281 200 mg BID (Panel B)	NA	± NA
Pt 1: MK-3281 400 mg BID (Panel C)	NA	± NA
Pt 1: MK-3281 800 mg BID (Panel D)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel E)	6.78	± 23.9
Pt 2: MK-3281 800 mg BID (Panel F)	5.60	± 33.3
Pt 2: MK-3281 1200 mg BID (Panel G)	10.73	± 40.5

Day 10

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	1.28	± 28.3
Pt 1: MK-3281 200 mg BID (Panel B)	3.45	± 36.2
Pt 1: MK-3281 400 mg BID (Panel C)	4.97	± 44.1
Pt 1: MK-3281 800 mg BID (Panel D)	7.83	± 48.8
Pt 2: MK-3281 800 mg BID (Panel E)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel F)	NA	± NA
Pt 2: MK-3281 1200 mg BID (Panel G)	NA	± NA

12-Hour Concentration of MK-3281 in Plasma (C12hr) Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.

Day 1

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	0.26	± 42.3
Pt 1: MK-3281 200 mg BID (Panel B)	0.61	± 35.2
Pt 1: MK-3281 400 mg BID (Panel C)	0.70	± 40.5
Pt 1: MK-3281 800 mg BID (Panel D)	0.95	± 73.1
Pt 2: MK-3281 800 mg BID (Panel E)	0.76	± 29.7
Pt 2: MK-3281 800 mg BID (Panel F)	0.64	± 66.1
Pt 2: MK-3281 1200 mg BID (Panel G)	0.64	± 26.6

Day 7

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	NA	± NA
Pt 1: MK-3281 200 mg BID (Panel B)	NA	± NA
Pt 1: MK-3281 400 mg BID (Panel C)	NA	± NA
Pt 1: MK-3281 800 mg BID (Panel D)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel E)	3.62	± 25.7
Pt 2: MK-3281 800 mg BID (Panel F)	3.09	± 26.9
Pt 2: MK-3281 1200 mg BID (Panel G)	4.90	± 32.1

Day 10

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	0.64	± 40.3
Pt 1: MK-3281 200 mg BID (Panel B)	1.66	± 32.1
Pt 1: MK-3281 400 mg BID (Panel C)	1.86	± 26.3
Pt 1: MK-3281 800 mg BID (Panel D)	2.87	± 24.2
Pt 2: MK-3281 800 mg BID (Panel E)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel F)	NA	± NA
Pt 2: MK-3281 1200 mg BID (Panel G)	NA	± NA

Time To Reach Cmax (Tmax) of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.

Day 1

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	3.0	1.5 – 6.0
Pt 1: MK-3281 200 mg BID (Panel B)	2.0	1.5 – 3.0
Pt 1: MK-3281 400 mg BID (Panel C)	5.0	3.0 – 6.0
Pt 1: MK-3281 800 mg BID (Panel D)	3.0	1.5 – 4.0
Pt 2: MK-3281 800 mg BID (Panel E)	2.5	1.4 – 4.0
Pt 2: MK-3281 800 mg BID (Panel F)	3.0	1.5 – 6.0
Pt 2: MK-3281 1200 mg BID (Panel G)	3.0	3.0 – 3.1

Day 7

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	NA	NA – NA
Pt 1: MK-3281 200 mg BID (Panel B)	NA	NA – NA
Pt 1: MK-3281 400 mg BID (Panel C)	NA	NA – NA
Pt 1: MK-3281 800 mg BID (Panel D)	NA	NA – NA
Pt 2: MK-3281 800 mg BID (Panel E)	2.3	0.0 – 2.8
Pt 2: MK-3281 800 mg BID (Panel F)	2.0	1.0 – 3.0
Pt 2: MK-3281 1200 mg BID (Panel G)	1.0	0.0 – 1.5

Day 10

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	3.5	2.0 – 4.0
Pt 1: MK-3281 200 mg BID (Panel B)	3.0	2.0 – 4.0
Pt 1: MK-3281 400 mg BID (Panel C)	3.5	1.5 – 6.0
Pt 1: MK-3281 800 mg BID (Panel D)	3.0	1.5 – 4.0
Pt 2: MK-3281 800 mg BID (Panel E)	NA	NA – NA
Pt 2: MK-3281 800 mg BID (Panel F)	NA	NA – NA
Pt 2: MK-3281 1200 mg BID (Panel G)	NA	NA – NA

Apparent Half-Life (t ½) of MK-3281 Secondary · Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)

Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.

Day 7

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	NA	± NA
Pt 1: MK-3281 200 mg BID (Panel B)	NA	± NA
Pt 1: MK-3281 400 mg BID (Panel C)	NA	± NA
Pt 1: MK-3281 800 mg BID (Panel D)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel E)	18.3	± 4.0
Pt 2: MK-3281 800 mg BID (Panel F)	19.7	± 3.3
Pt 2: MK-3281 1200 mg BID (Panel G)	19.5	± 2.0

Day 10

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	17.2	± 2.3
Pt 1: MK-3281 200 mg BID (Panel B)	17.5	± 2.9
Pt 1: MK-3281 400 mg BID (Panel C)	17.4	± 2.5
Pt 1: MK-3281 800 mg BID (Panel D)	16.9	± 1.3
Pt 2: MK-3281 800 mg BID (Panel E)	NA	± NA
Pt 2: MK-3281 800 mg BID (Panel F)	NA	± NA
Pt 2: MK-3281 1200 mg BID (Panel G)	NA	± NA

AUC (0-12hr) Accumulation Ratio of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	2.3	1.6 – 3.4
Pt 1: MK-3281 200 mg BID (Panel B)	2.4	1.6 – 3.5
Pt 1: MK-3281 400 mg BID (Panel C)	2.8	1.9 – 4.1
Pt 1: MK-3281 800 mg BID (Panel D)	3.7	2.5 – 5.6
Pt 2: MK-3281 800 mg BID (Panel E)	4.8	3.6 – 6.4
Pt 2: MK-3281 800 mg BID (Panel F)	4.5	3.7 – 5.6
Pt 2: MK-3281 1200 mg BID (Panel G)	7.3	4.9 – 11.1

Cmax Accumulation Ratio of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	1.7	1.2 – 2.6
Pt 1: MK-3281 200 mg BID (Panel B)	2.0	1.3 – 3.0
Pt 1: MK-3281 400 mg BID (Panel C)	2.8	1.8 – 4.2
Pt 1: MK-3281 800 mg BID (Panel D)	2.9	1.9 – 4.4
Pt 2: MK-3281 800 mg BID (Panel E)	4.2	3.0 – 5.9
Pt 2: MK-3281 800 mg BID (Panel F)	3.5	2.7 – 4.4
Pt 2: MK-3281 1200 mg BID (Panel G)	6.4	4.0 – 10.1

C12hr Accumulation Ratio of MK-3281 Secondary · Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)

Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.

Group	Value	95% CI
Pt 1: MK-3281 100 mg BID (Panel A)	2.5	1.6 – 4.1
Pt 1: MK-3281 200 mg BID (Panel B)	2.7	1.7 – 4.4
Pt 1: MK-3281 400 mg BID (Panel C)	2.6	1.6 – 4.3
Pt 1: MK-3281 800 mg BID (Panel D)	3.0	1.9 – 4.9
Pt 2: MK-3281 800 mg BID (Panel E)	4.7	3.6 – 6.2
Pt 2: MK-3281 800 mg BID (Panel F)	4.8	4.0 – 5.8
Pt 2: MK-3281 1200 mg BID (Panel G)	7.7	5.3 – 11.2

Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days Secondary · Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was

Group	Value	95% CI
Pt 2: MK-3281 800 mg BID (Panels E+F)	1.95	1.36 – 2.54
Pt 2: MK-3281 1200 mg BID (Panel G)	1.34	-0.34 – 3.01
Placebo	0.37	0.20 – 0.54

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 days after the last dose of study drug (up to 24 days maximum). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pt 1: MK-3281 100 mg BID (Panel A)

Serious: 0/7 (0%)

Deaths: —

Pt 1: MK-3281 200 mg BID (Panel B)

Serious: 0/6 (0%)

Deaths: —

Pt 1: MK-3281 400 mg BID (Panel C)

Serious: 0/6 (0%)

Deaths: —

Pt 1: MK-3281 800 mg BID (Panel D)

Serious: 0/6 (0%)

Deaths: —

Pt 2: MK-3281 800 mg BID (Panel E)

Serious: 0/6 (0%)

Deaths: —

Pt 2: MK-3281 800 mg BID (Panel F)

Serious: 0/12 (0%)

Deaths: —

Pt 2: MK-3281 1200 mg BID (Panel G)

Serious: 0/3 (0%)

Deaths: —

Placebo

Serious: 0/14 (0%)

Deaths: —

Other adverse events (54 terms — click to expand)

Reaction	System	Pt 1: MK-3281 100 mg BID (…	Pt 1: MK-3281 200 mg BID (…	Pt 1: MK-3281 400 mg BID (…	Pt 1: MK-3281 800 mg BID (…	Pt 2: MK-3281 800 mg BID (…	Pt 2: MK-3281 800 mg BID (…	Pt 2: MK-3281 1200 mg BID …	Placebo
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Catheter site haematoma	General disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Loss of libido	Psychiatric disorders	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Heat rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Application site irritation	General disorders	—	—	—	—	—	—	—	—
Catheter site inflammation	General disorders	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—
Device breakage	General disorders	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—	—	—	—
Rash pustular	Infections and infestations	—	—	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Excoriation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Procedural complication	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT00635804 adverse events section.

Sponsor's own description

This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days in HCV-infected male participants is sufficiently safe and well tolerated, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. The results of this study will guide dose selection for future studies in both healthy participants and HCV-infected participants.

Publications & conference data

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

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00635804 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 5 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00635804.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00635804

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Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Hepatitis C

Other Merck Sharp & Dohme LLC trials

Verify against primary sources