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A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: JNJ-54861911 (Drug); Caffeine (Drug); Midazolam (Drug); Tolbutamide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Summary

The purpose of this study is to assess the effects of single and multiple once daily doses of 50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in healthy male participants.

Clinical Details

Official title: An Open-Label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple-Doses of JNJ-54861911 With a Drug "Cocktail" Representative for CYP3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Concentration (Tmax)

Time to Last Quantifiable Plasma Concentration (Tlast)

Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])

Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24])

Elimination Half-Life (t1/2)

Elimination Rate Constant (lambda[z])

Secondary outcome: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Detailed description: This is a single-center, open-label (participants and researchers are aware about the treatment, participants are receiving), fixed-sequence study in healthy male participants. The study consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose administration on Day 1), Open Label Treatment Phase (Day 1 up to Day 9), and Follow-up Phase (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal). The maximum duration of study will be 7 weeks per participant. During the Open-Label Treatment Phase, participants will receive JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9. Blood samples will be collected pre-dose (Day 1) up to Day 10 to understand the PK characteristics of midazolam, 1-hydroxy midazolam (midazolam metabolite), caffeine, paraxanthine (caffeine metabolite), tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide

(tolbutamide metabolites). In addition, a blood sample will be collected on Day - 1 from all

enrolled participants to study genetic factors that may influence the PK, safety, and/or tolerability of JNJ-54861911 and co-medications. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Signed an informed consent document indicating they understand the purpose of and

procedures required for the study, and are willing to participate in the study

- Body mass index between 18 and 30 kilogram per square meter

- Must be healthy on the basis of physical examination, medical history, vital signs,

and 12-lead electrocardiogram (ECG) performed at Screening or admission (up to Day 1 pre-dose)

- Man, who is sexually active with a woman of child-bearing potential and has not had a

vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator, and must also agree to not donate sperm during the study and for 90 days after receiving the last dose of study drug

- Participant must be healthy on the basis of clinical laboratory tests performed at

Screening as per Investigator's judgment Exclusion Criteria:

- History of or current liver or renal insufficiency, closed-angle glaucoma,

significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, dermatological or metabolic disturbances

- Known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients,

sulfonamides, midazolam, caffeine or tolbutamide.

- History of human immunodeficiency virus (HIV) antibody positive, or tests positive

for HIV at Screening

- History of drug or alcohol abuse according to current Diagnostic and Statistical

Manual of Mental Disorders (DSM) criteria within 6 months before Screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, metamphetamines, benzodiazepines and cotinine) at Screening or admission

- Smoking of cigarettes (or equivalent) and/or used nicotine based products within 3

months prior to study drug administration

Locations and Contacts

Groningen, Netherlands
Additional Information

Starting date: September 2014
Last updated: November 20, 2014

Page last updated: August 23, 2015

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