NCT01813552

Brief Summary

This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

28 days

First QC Date

March 13, 2013

Last Update Submit

January 21, 2016

Conditions

Chronic Hepatitis C Infection

Keywords

HCVHepatitis Cantiviral drugsliver

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration

    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours

  • Pharmacokinetic parameter: AUC from time zero to infinity

    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours

  • Pharmacokinetic parameter: Maximum observed drug concentration (Cmax)

    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours

Secondary Outcomes (3)

  • Percentage of participants who experienced at least one serious adverse event

    Up to 17 days

  • Percentage of participants who experienced at least one adverse event

    Up to 17 days

  • Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality

    Up to 17 days

Study Arms (2)

Samatasvir + Ritonavir

EXPERIMENTAL

Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water.

Drug: SamatasvirDrug: Ritonavir

Samatasvir + Omeprazole

EXPERIMENTAL

Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke.

Drug: SamatasvirDrug: Omeprazole

Interventions

SamatasvirDRUG

Samatasvir 150 mg oral tablets (50mg x 3), single dose

Samatasvir + OmeprazoleSamatasvir + Ritonavir
OmeprazoleDRUG

40 mg delayed-release oral capsules, once daily

Samatasvir + Omeprazole
RitonavirDRUG

100 mg oral tablets, once daily

Samatasvir + Ritonavir

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All participants of childbearing potential must agree to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.

You may not qualify if:

  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

samatasvirOmeprazoleRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiazolesAzoles

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 19, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 22, 2016

Record last verified: 2016-01