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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2014-005448-17-GB
• Date of registration: 24/03/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen Sciences Ireland UC
• Public title: 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
• Scientific title: A Phase 1, open-label, randomized, 2-panel, 3-way crossover study in healthy adult subjects to assess the relative bioavailability of simeprevir following single dose administration of age-appropriate oral formulation candidates, compared to the 150-mg oral capsule, and to assess the effect of food on the bioavailability of simeprevir following single dose administration of a selected age-appropriate oral formulation candidate.
• Date of first enrolment: 09/04/2015
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005448-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 12
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

Product Name: JNJ-38733214-AAA (G019)
Product Code: TMC435 (or R494617)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other descriptive name: JNJ-38733214-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: OLYSIO
Product Name: JNJ-38733214-AAA (G028)
Product Code: TMC435 (or R494617)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other descriptive name: JNJ-38733214-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: JNJ-38733214-AAA (G045)
Product Code: TMC435, R494617
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other descriptive name: JNJ-38733214-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: JNJ-38733214-AAA (G047)
Product Code: TMC435, R494617
Pharmaceutical Form: Capsule
INN or Proposed INN: Simeprevir
Current Sponsor code: TMC435
Other descriptive name: JNJ-38733214-AAA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): - Maximum Plasma Concentration (Cmax) of Simeprevir (SMV)
- Time to Reach the Maximum Plasma Concentration (Tmax) of SMV
- Area Under the Plasma Concentration-Time Curve From 0 to last (AUC[0-last]) Post Dose of SMV
- Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of SMV
- Elimination Rate Constant (Lambda [z]) of SMV
- Terminal Half-life (t[1/2]) of SMV

Main Objective: - To compare the rate and extent of absorption of SMV following administration of a single dose of two different oral formulation candidates and following administration of a single dose of the 150-mg oral capsule, after a standardized breakfast in healthy adult subjects.
- To compare the rate and extent of absorption of SMV following administration of a single dose of a selected oral formulation candidate in the fed (standardized breakfast) and fasted state in healthy adult subjects.
- To compare the rate and extent of absorption of SMV following administration of a single dose of a selected oral formulation candidate after intake with water and after intake with yoghurt or apple juice, after a standardized breakfast in healthy adult subjects.

Secondary Objective: - To evaluate the short-term safety and tolerability of SMV following administration of three single oral doses of 150 mg, given as different formulations in healthy adult subjects.
- To assess the acceptability of the taste of a selected oral formulation candidate.

Timepoint(s) of evaluation of this end point: All primary endpoints: baseline up to 72 hours post-administration of study drug

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 - 5 to 15 minutes post-administration of study drug (up to Day 19)
2 - Screening up to follow-up (7 days after last dose administration)

Secondary end point(s): 1 - Number of Participants within Each Category of Taste Questionnaire
2 - Number of Participants with Adverse Events (AEs) and Serious AEs

Secondary ID(s)

TMC435HPC1010

Source(s) of Monetary Support

Janssen Sciences Ireland UC

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 04/08/2016
• Date Completed: 09/09/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-005448-17/results