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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02103985

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

32

Starts

2009-05-01

Expected to finish

2009-06-01

Last updated by the study team

2014-06-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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