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

Chronic Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813552
• Other study ID #: 1894-006
• Secondary ID: IDX-06A-006
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: January 21, 2016
• Start date: February 2013
• Est. completion date: March 2013

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Samatasvir
Samatasvir 150 mg oral tablets (50mg x 3), single dose
• Omeprazole
40 mg delayed-release oral capsules, once daily
• Ritonavir
100 mg oral tablets, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentage of participants who experienced at least one serious adverse event		Up to 17 days	Yes
Secondary	Percentage of participants who experienced at least one adverse event		Up to 17 days	Yes
Secondary	Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality		Up to 17 days	Yes