A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants

NCT01986491 | Completed Phase 1

• 2 other identifiers: CR01626439393406EDI1003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.

Conditions

Healthy

Keywords

Healthy; JNJ-39393406; Relative Bioavailability; Solid Formulation

Outcome Measures

Primary Outcomes (4)

• Maximum plasma concentration of JNJ 39393406

  Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data

  Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)

• Time to reach the maximum plasma concentration of JNJ 39393406

  Time to reach the maximum plasma concentration, determined by visual inspection of the data

  Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3)

• Area under the plasma concentration-time curve of JNJ-39393406

  Predose to 96 hrs postdose (Part 1 and Part 2 [after each single-dose administration]); predose to 24 hrs postdose (Day 1); predose to 5 hrs postdose (Days 3 and 5); predose to 96 hrs (Day 8), and end of study (7 to 14 days after the last dose) (Part 3

• Number of participants with adverse events

  Up to 7 to 14 days after last dose of study medication (Part 1, Part 2, and Part 3)

Study Arms (7)

Part 1; Period 1

EXPERIMENTAL

Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y

Part 1; Period 2

EXPERIMENTAL

Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y

Part 1; Period 3

EXPERIMENTAL

Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y

Part 1; Period 4

EXPERIMENTAL

Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y

Part 2; Period 1

EXPERIMENTAL

Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y; Drug: JNJ 39393406 30 mg solution

Part 2; Period 2

EXPERIMENTAL

Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y; Drug: JNJ 39393406 120 mg solid X; Drug: JNJ 39393406 120 mg solid Y; Drug: JNJ 39393406 30 mg solution

Part 3

EXPERIMENTAL

Eight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7.

Drug: JNJ 39393406 30 mg solid X; Drug: JNJ 39393406 30 mg solid Y

Interventions

JNJ 39393406 30 mg solid X DRUG

Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).

Part 1; Period 1; Part 1; Period 2; Part 1; Period 3; Part 1; Period 4; Part 2; Period 1; Part 2; Period 2; Part 3

JNJ 39393406 30 mg solid Y DRUG

Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

Part 1; Period 1; Part 1; Period 2; Part 1; Period 3; Part 1; Period 4; Part 2; Period 1; Part 2; Period 2; Part 3

JNJ 39393406 120 mg solid X DRUG

Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).

Part 1; Period 1; Part 1; Period 2; Part 1; Period 3; Part 1; Period 4; Part 2; Period 1; Part 2; Period 2

JNJ 39393406 120 mg solid Y DRUG

Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).

Part 1; Period 1; Part 1; Period 2; Part 1; Period 3; Part 1; Period 4; Part 2; Period 1; Part 2; Period 2

JNJ 39393406 30 mg solution DRUG

Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).

Part 2; Period 1; Part 2; Period 2

Eligibility Criteria

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

You may qualify if:

• Healthy male participants
• Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])
• Willing to adhere to the prohibitions and restrictions specified in the protocol
• Must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

• Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening or admission
• Clinically significant abnormal physical examination, neurological examination, vital signs or 12 lead electrocardiogram at screening
• Significant history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant
• Significant history of or current psychiatric or neurological illness
• Serology positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies at screening

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development 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: November 11, 2013
• First Posted: November 18, 2013
• Study Start: May 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

BE (1)