A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants

NCT01964872 | Completed Phase 1

• 3 other identifiers: CR10278438877618EDI10012013-002551-16
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult male participants.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; JNJ-38877618; Pharmacokinetic; Safety; Single-ascending dose; Multiple-ascending dose

Outcome Measures

Primary Outcomes (19)

• Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)

  Up to 30 days after the last dose of study medication

• Time to reach the maximum observed plasma concentration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Elimination half-life of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• First-order rate constant associated with the terminal portion of the curve of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Total clearance of drug after oral administration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Apparent volume of distribution after oral administration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

• Maximum observed plasma concentration during a dosing interval at steady state of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Minimum observed plasma concentration during a dosing interval at steady state of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Average plasma concentration over the dosing interval at steady state of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Trough observed plasma concentration at the end of dosing interval of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Time to reach the maximum observed plasma concentration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Area under the plasma concentration-time curve during a dosing interval of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Area under the plasma concentration-time curve during a dosing interval at steady-state of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Total clearance of drug after oral administration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Accumulation index of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

• Apparent volume of distribution at steady-state after oral administration of JNJ-38877618

  Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Secondary Outcomes (1)

• Maximum tolerated dose of JNJ-38877618

  Up to 30 days after last dose of study medication (up to Part 2)

Study Arms (2)

JNJ-38877618

EXPERIMENTAL

Drug: JNJ-38877618: Part 1a; Drug: JNJ-38877618: Part 1b; Drug: JNJ-38877618: Part 1c (optional); Drug: JNJ-38877618: Part 2; Drug: JNJ-38877618: Part 3; Drug: JNJ-38877618: Part 4 (optional)

Placebo

PLACEBO COMPARATOR

Drug: Placebo: Parts 1a, 2, 3, and 4 (optional)

Interventions

JNJ-38877618: Part 1a DRUG

Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

JNJ-38877618

JNJ-38877618: Part 1b DRUG

Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

JNJ-38877618

JNJ-38877618: Part 1c (optional) DRUG

Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

JNJ-38877618

JNJ-38877618: Part 2 DRUG

Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

JNJ-38877618

JNJ-38877618: Part 3 DRUG

Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.

JNJ-38877618

JNJ-38877618: Part 4 (optional) DRUG

Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.

JNJ-38877618

Placebo: Parts 1a, 2, 3, and 4 (optional) DRUG

Administered orally matched to study drug

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
• Must have good exercise tolerance
• Agrees to protocol-defined use of effective contraception
• Body Mass Index between 20 and 30 kg/m2 and body weight not less than 65 kg
• Non-nicotine user for 6 months prior to screening

You may not qualify if:

• Current history of clinically significant medical illness
• History of drug or alcohol abuse within 5 years
• Routine consumption of \>450 mg of caffeine per day
• Recent vaccination or acute illness
• Blood donation or major blood loss within 3 months prior to study drug administration
• Use of any prescription or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of dosing of the study drug or a proton pump inhibitor within 6 weeks prior to dosing of study drug
• Currently enrolled in an investigational study, or received an investigational drug or vaccine, or used an invasive investigational medical device within 3 months before the planned first dose of study drug
• Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
• Major surgery within 3 months before or after study participation or minor surgery within 6 weeks before screening, or 30 days after the last study drug administration
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (1)

Unknown Facility

Nottingham, United Kingdom

Location

Study Officials

• Janssen Cilag N.V./S.A., Belgium Clinical Trial

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

GB (1)