A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam

NCT01442532 | Completed Phase 1

• 2 other identifiers: CR10066938518168ARA1002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of Part 1 of this study is to evaluate the safety, tolerability, and pharmacokinetics ("PK", how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of JNJ-38518168 in comparison with placebo following single dose and 14 days of consecutive dosing in healthy Japanese and Caucasian adult male participants. Part 2 of this study will evaluate the effect of JNJ-38518168 on the pharmacokinetics of midazolam in healthy participants.

Conditions

Healthy Male Volunteer

Keywords

Healthy male volunteer; JNJ-38518168; Midazolam

Outcome Measures

Primary Outcomes (5)

• The number of Japanese participants with adverse events

  Up to 10 weeks

• Blood tests in Japanese participants

  Up to 10 weeks

• Clinical laboratory tests in Japanese participants

  Up to 10 weeks

• Electrocardiograms in Japanese participants

  Up to 10 weeks

• Blood levels of JNJ-38518168 in all participants

  Up to 10 weeks

Secondary Outcomes (4)

• The number of Caucasian participants with adverse events

  Up to 10 weeks

• Blood tests in Caucasian participants

  Up to 10 weeks

• Clinical laboratory tests in Caucasian participants

  Up to 10 weeks

• Electrocardiograms in Caucasian participants

  Up to 10 weeks

Study Arms (5)

1

EXPERIMENTAL

Drug: JNJ-38518168 (30 mg)

2

EXPERIMENTAL

Drug: JNJ-38518168 (10 mg)

3

EXPERIMENTAL

Drug: JNJ-38518168 (3 mg)

4

PLACEBO COMPARATOR

Drug: Placebo

5

EXPERIMENTAL

Drug: Midazolam and JNJ-38518168

Interventions

JNJ-38518168 (30 mg) DRUG

Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days

1

JNJ-38518168 (10 mg) DRUG

Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days

2

JNJ-38518168 (3 mg) DRUG

Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days

3

Placebo DRUG

Form=tablet, route=oral use, for 14 days

4

Midazolam and JNJ-38518168 DRUG

Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15

5

Eligibility Criteria

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

You may qualify if:

• Part 1 only:
• Male, 20 to 55 years of age.
• Be either:
• Of Japanese descent who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report. Japanese participants must have a valid Japanese passport.
• A non-Hispanic Caucasian participant who has Caucasian parents as determined by participant's verbal report.
• Have a body mass index (BMI) of 18.5 kg/m2 to 25 kg/m2 for participants of Japanese descent and between 18.5 kg/m2 and 30 kg/m2 for Caucasian participants.
• Have a body weight of not less than 50 kg.
• Part 2 only:
• Male, 18 to 55 years of age
• Have a BMI of 18.5 kg/m2 to 30 kg/m2 and have a body weight of not less than 50 kg.
• For both Parts 1 and 2:
• Be otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and ECG. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judge the abnormalities or deviations from normal to be not clinically significant.
• If a man is heterosexually active with a woman of childbearing potential, he must be surgically sterile or agree to use a double-barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Have a blood pressure measurement between 90 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, at screening.
• Have a 12-lead ECG consistent with normal cardiac conduction and function at screening.

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
• History of hypersensitivity to or intolerance of midazolam (Part 2 only)
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
• Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or admission to the study center in Period 1 as deemed appropriate by the investigator.
• Has any known malignancy or a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study drug).

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC & Development, L.L.C., Clinical Trial

  Janssen Research & Development, LLC

  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: September 27, 2011
• First Posted: September 28, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

US (1)