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

NCT02103985 | Completed Phase 1

• 2 other identifiers: CR015718TPI1062DEP1004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; JNJ-39823277; JNJ-40917006; Pharmacokinetics

Outcome Measures

Primary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) of JNJ-39823277

  The Cmax is defined as maximum observed analyte concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39823277

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-39823277

  The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-39823277

  The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Elimination Half-Life Period (T1/2) of JNJ-39823277

  The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of JNJ-40917006 (MC5 metabolite)

  The Cmax is defined as maximum observed analyte concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-40917006 (MC5 metabolite)

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-40917006 (MC5 metabolite)

  The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-40917006 (MC5 metabolite)

  The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

• Elimination Half-Life Period (T1/2) of JNJ-40917006 (MC5 metabolite)

  The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

  Pre-dose; and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 hours post-dose

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 6 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition.

Drug: JNJ-39823277

Treatment B

EXPERIMENTAL

Participants will receive 100 mg JNJ-39823277 under fasted condition.

Drug: JNJ-39823277

Interventions

JNJ-39823277 DRUG

Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.

Also known as: TPI-1062

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

US (1)