NCT02262715

Brief Summary

The purpose of this study is to investigate the drug-drug interaction between VX-787 and oseltamivir, when co-administered at steady-state in healthy participants. In addition the safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of VX-787 will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2014

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

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

August 26, 2014

Last Update Submit

November 3, 2014

Conditions

Healthy

Keywords

OseltamivirVX-787

Outcome Measures

Primary Outcomes (3)

  • Assess the drug-drug interaction between VX-787 600 mg bid coadministered with oseltamivir 75 mg bid at steady-state in healthy participants

    Based on the individual plasma concentration-time data, using the actual sampling times the following PK parameters will be derived: Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/refrence (ref), Ratio Cmin,test/ref and ratio AUC12h, test/ref

    Day 5

  • Evaluate the safety and tolerability of a VX-787 600 mg bid regimen during 10 days in healthy participants

    Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams.

    Days 1-10

  • Assessment of Pharmacokinetics of VX-787

    Pharmacokinetic parameters will include assessment of Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/ref, ratio Cmin,test/ref and ratio AUC12h,test/ref.

    Days 1-10

Secondary Outcomes (1)

  • Investigate the short-term safety and tolerability of the concomitant use of VX-787 and oseltamivir in healthy participants

    Days 1-5

Study Arms (3)

Part 1

EXPERIMENTAL

Participants will receive in random order Treatment A (VX-787, 600 mg tablet 2 times a day on Day 1 to 4, followed by VX 787, 600 mg tablet on Day 5); Treatment B (Oseltamivir, 75 mg capsule 2 times a day on Day 1 to 4, followed by oseltamivir 75 mg capsule in the morning on Day 5) or Treatment C (VX-787, 600 mg tablet, 2 times a day orally + oseltamivir, 75 mg capsule, 2 times a day on Day 1 to 4, followed by a single dose of VX-787, 600 mg + oseltamivir, 75 mg capsule on Day 5). Each participant will receive all three treatments (Treatment A, B and C) in a random sequence.

Drug: VX-787Drug: Oseltamivir

Part 2 VX-787

EXPERIMENTAL

Participants will receive VX-787, 600 mg, tablet 2 times a day, orally on Day 1 to Day 9, followed by single dose of VX-787, 600 mg on Day 10.

Drug: VX-787

Part 2 Placebo

EXPERIMENTAL

Participants will receive placebo matching to VX-787, 2 times a day, orally on Day 1 to Day 9, followed by single dose of matching placebo on Day 10.

Other: Placebo

Interventions

VX-787DRUG

Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.

Part 1Part 2 VX-787
OseltamivirDRUG

Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.

Part 1
PlaceboOTHER

Participants will receive placebo matching to VX-787 either two times a day or or once a day.

Part 2 Placebo

Eligibility Criteria

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

You may qualify if:

  • Female participants must be of non-childbearing potential: postmenopausal for at least 2 years (amenorrheal for at least 3 years and a serum follicle stimulating hormone \[FSH\] level greater than \[\>\] 40 international unit per liter \[IU/L\]), or surgically sterile (have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant
  • Participants must be non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening
  • Participants must have a Body Mass Index (BMI: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square \[kg/m\^2\]
  • Participants must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
  • Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs and the results of blood biochemistry, blood coagulation and hematology test and a urinalysis performed at screening

You may not qualify if:

  • Participants with a past history of heart arrhythmias (for example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
  • Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 1 year, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
  • Participants with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B infection (confirmed by hepatitis B surface antigen \[HBsAg\]), or hepatitis C infection (confirmed by hepatitis C virus \[HCV\] antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
  • Participants having a positive urine drug test or alcohol breath test at study screening. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates
  • Participants with known allergies, hypersensitivity, or intolerance to VX-787, oseltamivir, or excipients of the drug products used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

pimodivirOseltamivir

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Janssen Infectious Diseases BVBA Clinical Trial

    Janssen Infectious Diseases BVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

October 13, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

BE(1)