Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to assess the effect of multiple doses of itraconazole or gemfibrozil on the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-56021927 and its metabolites (JNJ 56142060 and JNJ-56142021) in healthy male participants.

Key facts

Study ID

NCT02230033

Run by

Aragon Pharmaceuticals, Inc.

People needed

45

Starts

2014-09-01

Expected to finish

2014-12-01

Last updated by the study team

2016-10-20

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Must agree to use an adequate contraception method as deemed appropriate by the Investigator and specified in protocol, always use a condom during sexual intercourse, and to not donate sperm during the study and for 3 months after receiving the study drug
• Body mass index between 18 and 30 kilogram (kg) per square meter, and body weight not less than 50 kg
• Blood pressure (supine for 5 minutes) between 90 and 140 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening, including: Pulse rate between 45 and 99 beats per minute (bpm); QTc interval less than or equal to (<=) 450 milliseconds; QRS interval of less than (<) 120 milliseconds; PR interval <220 milliseconds; and morphology consistent with healthy cardiac conduction and function
• Nonsmoker within the previous 2 months (calculated from first dosing)

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
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at Screening or at admission to the study center as deemed appropriate by the Investigator
• Medical history of gallbladder disease (cholecystitis, cholelithiasis, cholecystectomy)
• Presence of sexual dysfunction or any medical condition that would affect sexual function
• Screening serum testosterone level of < 200 nanogram/deciliter (ng/dL)
• Previous history of photoallergy or phototoxic reaction during treatment with fibrates

Where it is running

• Study site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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