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A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants

NCT02385071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-09-07

No results posted yet for this study

Summary

The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of simeprevir (SMV) following single dose administration of age-appropriate oral formulation candidates compared to the 150 milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV following single dose administration of a selected age-appropriate oral formulation candidate.

Conditions

  • Healthy

Interventions

DRUG

Treatment A

150 milligram (mg) SMV capsule with water under fed conditions.

DRUG

Treatment B

Treatment B (3\*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.

DRUG

Treatment C

Treatment C (3\*50 mg dispersible SMV tablets dispersed in water under fed conditions).

DRUG

Treatment D

\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fed conditions.

DRUG

Treatment E

3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3\*50 mg dispersible SMV tablets dispersed in water under fasted conditions.

DRUG

Treatment F

3\*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3\*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2015-09-09
Completion
2015-09-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385071 on ClinicalTrials.gov