A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Cross-over Study to Investigate the Relative Bioavailability of Setrobuvir (STV) Tablet Formulation Versus the Reference Setrobuvir Capsule Formulation Following Oral Administration With or Without a High Fat Meal in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612143
• Other study ID #: NP28327
• Secondary ID: 2012-001001-24
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2012
• Last updated: November 1, 2016
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and female adults, 18 to 55 years of age inclusive

• Body mass index (BMI) 18.0 - 30.0 kg/m2

• Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination

• Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug

• Non-smokers or use of < 10 cigarettes (or equivalent nicotine-containing product) per day

• Negative results on following screening laboratory test: urine drug screen, urine alcohol screen

• Willing and able to consume the study-specified meal on day of dosing

Exclusion Criteria:

• Pregnant or lactating women, or males with female partners who are pregnant or lactating

• History of current alcohol abuse and/or other drug addiction </= 2 years prior to enrollment in the study

• Participation in other clinical studies within 60 days prior to study randomization

• Positive for hepatitis B, hepatitis C or HIV infection

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• setrobuvir
200 mg capsule formulation, single oral dose
• setrobuvir
200 mg tablet formulation, single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability: Cmax/area under the concentration-time curve (AUC)		Pre-dose and up to 168 hours post-dose	No
Secondary	Safety: Incidence of adverse events		approximately 2 months	No