NCT01390428 is a Phase 1 clinical trial of Grazoprevir in Hepatitis C, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT01390428?

NCT01390428 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT01390428?

Interventions in NCT01390428: Grazoprevir.

What condition does NCT01390428 study?

NCT01390428 studies Hepatitis C.

Is NCT01390428 still recruiting?

NCT01390428 is currently completed. Last updated 14 September 2018.

Are results published for NCT01390428?

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

Last reviewed 2018-09-14 · How we verify

NCT01390428

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

Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)

Completed Phase 1 Results posted Last updated 14 September 2018

What this trial tests

Phase 1 trial testing Grazoprevir in Hepatitis C in 50 participants. Completed in 12 September 2014.

Timeline

28 July 2011

Primary endpoint
5 September 2014

12 September 2014

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	28 July 2011
Primary completion	5 September 2014
Estimated completion	12 September 2014

Drugs / interventions tested

Grazoprevir (GRAZOPREVIR) — 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, any sex, 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.

Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir Primary · Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Day 1

Group	Value	95% CI
Part 1-Mild HI	1.71	1.10 – 2.65
Part 1-Healthy Matched to Mild HI	1.42	0.912 – 2.20
Part 2-Moderate HI	1.61	0.791 – 3.29
Part 2-Healthy Matched to Moderate HI	0.321	0.157 – 0.655
Part 3-Severe HI	1.17	0.541 – 2.55
Part 3-Healthy Matched to Severe HI	0.0592	0.0273 – 0.129

Day 10

Group	Value	95% CI
Part 1-Mild HI	6.20	4.19 – 9.18
Part 1-Healthy Matched to Mild HI	3.74	2.53 – 5.54
Part 2-Moderate HI	4.21	2.48 – 7.14
Part 2-Healthy Matched to Moderate HI	0.874	0.515 – 1.48
Part 3-Severe HI	3.00	1.71 – 5.26
Part 3-Healthy Matched to Severe HI	0.257	0.146 – 0.451

Maximum Concentration (Cmax) of Grazoprevir Primary · Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Day 1

Group	Value	95% CI
Part 1-Mild HI	0.257	0.121 – 0.545
Part 1-Healthy Matched to Mild HI	0.305	0.144 – 0.646
Part 2-Moderate HI	0.433	0.184 – 1.07
Part 2-Healthy Matched to Moderate HI	0.0580	0.0242 – 0.139
Part 3-Severe HI	0.238	0.107 – 0.531
Part 3-Healthy Matched to Severe HI	0.0157	0.00705 – 0.0350

Day 10

Group	Value	95% CI
Part 1-Mild HI	1.40	0.903 – 2.17
Part 1-Healthy Matched to Mild HI	1.02	0.658 – 1.58
Part 2-Moderate HI	0.631	0.334 – 1.19
Part 2-Healthy Matched to Moderate HI	0.106	0.0559 – 0.199
Part 3-Severe HI	0.396	0.203 – 0.774
Part 3-Healthy Matched to Severe HI	0.0304	0.0156 – 0.0595

Time to Peak Concentration (Tmax) of Grazoprevir Primary · Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Day 1

Group	Value	95% CI
Part 1-Mild HI	3.50	1.00 – 12.00
Part 1-Healthy Matched to Mild HI	2.50	1.00 – 4.00
Part 2-Moderate HI	2.00	1.50 – 4.00
Part 2-Healthy Matched to Moderate HI	1.75	1.00 – 4.00
Part 3-Severe HI	1.75	1.00 – 3.00
Part 3-Healthy Matched to Severe HI	1.50	1.00 – 4.00

Day 10

Group	Value	95% CI
Part 1-Mild HI	3.00	2.00 – 4.00
Part 1-Healthy Matched to Mild HI	3.01	1.5 – 4.00
Part 2-Moderate HI	3.00	1.50 – 8.00
Part 2-Healthy Matched to Moderate HI	2.00	1.00 – 6.00
Part 3-Severe HI	1.75	0.50 – 4.00
Part 3-Healthy Matched to Severe HI	1.00	0.50 – 3.00

Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI Primary · Day 1 at 24 hours postdose

Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Group	Value	95% CI
Part 1-Mild HI	21.4	18.2 – 25.2
Part 1-Healthy Matched to Mild HI	11.5	9.8 – 13.5
Part 2-Moderate HI	17.7	8.73 – 35.8
Part 2-Healthy Matched to Moderate HI	5.90	2.92 – 11.9

Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI Primary · Day 1 at 24 hours postdose

Group	Value	95% CI
Part 3-Severe HI	15.6	2.89 – 60.2
Part 3-Healthy Matched to Severe HI	1.86	0.00 – 3.32

Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10 Primary · Days 10 at 24 hours postdose

Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Group	Value	95% CI
Part 1-Mild HI	32.6	24.8 – 42.8
Part 1-Healthy Matched to Mild HI	17.0	12.9 – 22.3
Part 2-Moderate HI	48.9	27.2 – 87.9
Part 2-Healthy Matched to Moderate HI	13.6	7.60 – 24.5
Part 3-Severe HI	55.0	31.9 – 94.8
Part 3-Healthy Matched to Severe HI	5.89	3.42 – 10.2

Apparent Terminal Half-life (t1/2) of Grazoprevir Primary · Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.

Group	Value	95% CI
Part 1-Mild HI	54.24	± 22.32
Part 1-Healthy Matched to Mild HI	35.85	± 47.15
Part 2-Moderate HI	39.59	± 23.76
Part 2-Healthy Matched to Moderate HI	39.80	± 17.34
Part 3-Severe HI	42.00	± 26.55
Part 3-Healthy Matched to Severe HI	31.02	± 41.99

Adverse events — posted to ClinicalTrials.gov

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

Part 1-Mild HI

Serious: 0/8 (0%)

Deaths: —

Part 1-Healthy Matched to Mild HI

Serious: 0/8 (0%)

Deaths: —

Part 2-Moderate HI

Serious: 0/9 (0%)

Deaths: —

Part 2-Healthy Matched to Moderate HI

Serious: 0/9 (0%)

Deaths: —

Part 3-Severe HI

Serious: 1/8 (13%)

Deaths: —

Part 3-Healthy Matched to Severe HI

Serious: 0/8 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Part 1-Mild HI	Part 1-Healthy Matched to …	Part 2-Moderate HI	Part 2-Healthy Matched to …	Part 3-Severe HI	Part 3-Healthy Matched to …
Postoperative ileus	Injury, poisoning and procedural complications	—	—	—	—	—	—

Other adverse events (47 terms — click to expand)

Reaction	System	Part 1-Mild HI	Part 1-Healthy Matched to …	Part 2-Moderate HI	Part 2-Healthy Matched to …	Part 3-Severe HI	Part 3-Healthy Matched to …
Headache	Nervous system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Faeces hard	Gastrointestinal disorders	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—
Rash pustular	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Weight increased	Investigations	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—
Abnormal dreams	Psychiatric disorders	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rhinalgia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Postoperative ileus.

Data from ClinicalTrials.gov NCT01390428 adverse events section.

Sponsor's own description

This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy 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:

Other trials of Grazoprevir

Trials testing the same drug.

NCT02601573 — Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic · Phase 2 · completed
NCT02332720 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo · Phase 2 · completed
NCT02332707 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo · Phase 2 · completed
NCT02203149 — Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058) · Phase 2, PHASE3 · completed
NCT02115321 — Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Chil · Phase 2, PHASE3 · completed

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

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 NCT01390428 (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: 14 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/NCT01390428.

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

NCT01390428

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Grazoprevir

Other recruiting trials for Hepatitis C

Other Merck Sharp & Dohme LLC trials

Verify against primary sources