To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01813552

Enrollment

Registered

2013-03-19

Start date

2013-02-28

Completion date

2013-03-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Keywords

HCV, Hepatitis C, antiviral drugs, liver

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.

Interventions

DRUGSamatasvir

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

DRUGOmeprazole

40 mg delayed-release oral capsules, once daily

DRUGRitonavir

100 mg oral tablets, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* Pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026