A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: JNJ-39823277

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103985

TPI1062DEP1004 (Other Identifier)

CR015718

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of food on the bioavailability of a single oral dose of JNJ-39823277 and its active metabolites.

Full description

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 2 treatment-sequence, and crossover study (method used to switch participants from one treatment arm to another in a clinical study). The study consist of 3 phases: a screening phase (within 21 days before medication administration), a 2-period open-label treatment phase, during which each participant will receive 1 of 2 open-label treatment sequences, and the end-of-study or withdrawal assessments (within 7-11 days after the last dose of the study medication). Participants will be randomly assigned to 1 of 2 treatment-sequences: Treatment Sequence AB (dosing in fed [with high fat diet] condition followed by dosing in fasted [without food] condition) or Treatment Sequence BA (dosing in fasted condition followed by dosing in fed condition). Study medication administrations will be separated by a washout period (period when receiving no treatment) of 7 to 14 days. The study duration for each participant will be approximately 6 weeks.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant must be a healthy male or non-lactating healthy female
Agrees to protocol-defined use of effective contraception
If a woman, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and on Day -1 of each treatment period
Agree to abstain from all medication (except for allowed birth control), including prescription and non-prescription (including vitamins and natural or herbal remedies)

Exclusion criteria

A history of clinically significant gastrointestinal, especially peptic ulcerations, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, especially those with a past history of depression, suicidal ideation or suicidal attempts, or cardiovascular disease
Acute diarrhea or constipation in the 7 days before the predicted first study day. If screen occurs >7 days before first study day, this criterion will be determined on Day -1
Participant has donated blood within 90 days or plasma within 30 days of study dosing
Participant has used any over-the-counter or prescription medication, including vitamins, within 14 days prior to the study with the exception of acetaminophen
Participant has consumed products containing grapefruit juice or grapefruit, Seville oranges (eg, orange marmalade), quinine (eg, tonic water), or xanthine (eg, chocolate, caffeine containing products) within 24 hours (72 hours in the case of grapefruit juice and Seville oranges) prior to start of study drug administration