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

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ClinicalTrials.gov Identifier: NCT02103985
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-39823277 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Two-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Male and Female Subjects
Study Start Date : May 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: Treatment A
Participants will receive 100 mg JNJ-39823277 under fed (after a high fat) condition.
Drug: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Other Name: TPI-1062

Experimental: Treatment B
Participants will receive 100 mg JNJ-39823277 under fasted condition.
Drug: JNJ-39823277
Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Other Name: TPI-1062




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-39823277 [ Time Frame: 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 ]
    The Cmax is defined as maximum observed analyte concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-39823277 [ Time Frame: 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 ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-39823277 [ Time Frame: 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 ]
    The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

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

  5. Elimination Half-Life Period (T1/2) of JNJ-39823277 [ Time Frame: 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 ]
    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).

  6. Maximum Observed Plasma Concentration (Cmax) of JNJ-40917006 (MC5 metabolite) [ Time Frame: 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 ]
    The Cmax is defined as maximum observed analyte concentration.

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-40917006 (MC5 metabolite) [ Time Frame: 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 ]
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  8. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of JNJ-40917006 (MC5 metabolite) [ Time Frame: 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 ]
    The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

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

  10. Elimination Half-Life Period (T1/2) of JNJ-40917006 (MC5 metabolite) [ Time Frame: 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 ]
    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).


Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103985


Locations
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United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT02103985     History of Changes
Other Study ID Numbers: CR015718
TPI1062DEP1004 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy
JNJ-39823277
JNJ-40917006
Pharmacokinetics