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

Phase 1

• Conditions: Chronic Hepatitus C Virus (HCV) Infection; MedDRA version: 17.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-005448-17-GB
• Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-24
• Study Completion: 2015-09-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

- Participants must be healthy on the basis of physical examination, medical history, 12-lead electrocardiogram (ECG) and vital signs performed at screening (after signing the ICF), and on Day -1
of the first treatment session, if applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- Female participants, except for postmenopausal women, should have a negative serum pregnancy test at screening
- All female participants should have a negative urine pregnancy test on Day -1 of the first treatment session
- Male participants heterosexually active with a woman of childbearing potential must agree to use two effective methods of birth control and all men must not donate sperm during the study and for at least 30 days after receiving the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Female participants who are pregnant or breast feeding at screening or on Day -1 of the first treatment session
- Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin [IgM]), or hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by HCV antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection
- Participants with a history or evidence of current or past abuse of alcohol, or recreational or narcotic drugs, which in the Investigator’s opinion would compromise the participant's safety and/or compliance with the study procedures
- Participants with any history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Participants with known allergies, hypersensitivity, or intolerance to simeprevir (SMV) or any of the excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified