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

Healthy Volunteers Clinical Trial

Official title:

A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964872
• Other study ID #: CR102784
• Secondary ID: 38877618EDI10012
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2013
• Last updated: September 11, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Janssen Cilag N.V./S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a single optional cohort in older healthy male participants aged 50 to 65 years may be included). If all optional cohorts are included, up to 144 participants may be enrolled. This study will consist of up to four parts. Part 1 contains up to 3 subparts: Part 1a is a double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2 is the completion of the double-blind, placebo-controlled SAD after a formulation has been selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind, placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined based on the safety, tolerability, and pharmacokinetics (study of what the body does to a drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics (study of what a drug does to the body) samples will be collected and safety will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• JNJ-38877618: Part 1a
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: Part 1b
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: Part 1c (optional)
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: Part 2
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: Part 3
Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
• JNJ-38877618: Part 4 (optional)
Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.
• Placebo: Parts 1a, 2, 3, and 4 (optional)
Administered orally matched to study drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Cilag N.V./S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Elimination half-life of JNJ-38877618		Up to 24 hours after last dose of study medication (up to Part 4 Day 2)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	Accumulation index of JNJ-38877618		Up to 24 hours after last dose of study medication (up to Part 3 Day 8)	No
Primary	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)	No
Secondary	Maximum tolerated dose of JNJ-38877618		Up to 30 days after last dose of study medication (up to Part 2)	No