NCT02071355

Brief Summary

The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

February 24, 2014

Last Update Submit

September 28, 2014

Conditions

Healthy

Keywords

HealthyChinese participantsTMC435Multiple oral dosesPharmacokineticsSafetyTolerability

Outcome Measures

Primary Outcomes (8)

  • Predose plasma concentration of TMC435

    Predose on Days 1, 5, 6, and 7

  • Minimum plasma concentration of TMC435

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Maximum plasma concentration of TMC435

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Time to reach the maximum plasma concentration of TMC435

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Area under the plasma concentration-time curve of TMC435 from time of administration up to 24 hours after dosing

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Area under the plasma concentration-time curve of TMC435 from time of administration up to the last time point with a measurable concentration after dosing

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Average steady-state plasma concentration of TMC435

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

  • Fluctuation index of TMC435

    Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x (\[Cmax-Cmin\]/Css,av). Css,av is an average steady-state plasma concentration.

    Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)

Secondary Outcomes (1)

  • Number of participants with adverse events

    Up to 47 days

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive 100 mg TMC435 once daily for 7 days.

Drug: TMC435 100 mg

Group 2

EXPERIMENTAL

Participants will receive 150 mg TMC435 once daily for 7 days.

Drug: TMC435 150 mg

Interventions

TMC435 100 mgDRUG

Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.

Group 1
TMC435 150 mgDRUG

Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.

Group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese participants on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
  • Must be non-smoking for at least 3 months prior to screening as confirmed by a urine cotinine test
  • A Body Mass Index (BMI) of 18.0 to 30.0 kg/square meter, extremes included (BMI is calculated as BMI = body weight in kg divided by the square of height in meters)
  • Participants must agree to use one of the contraception methods defined in the protocol

You may not qualify if:

  • Positive human immunodeficiency virus - type 1 and 2; syphilis; hepatitis A, B or C infection at screening
  • History or presence of liver or renal clearance insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic medicines use
  • Any history of significant skin disease such as but not limited to, rash or eruptions, allergies, dermatitis, eczema (inflammation of the skin), psoriasis (an inflammatory skin disease), or urticarial (a raised and itchy rash that appears on the skin)
  • Female participants who are breastfeeding at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

MeSH Terms

Interventions

Simeprevir

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 25, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09

Locations

CN(1)