Pharmacokinetic Study of JNJ-42756493 in Healthy Participants

NCT02218073 | Completed Phase 1

• 3 other identifiers: CR10499842756493EDI10022014-002634-31
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg) dose as an oral solution administered in combination with a single intravenous administration of a microdose (100 microgram \[mcg\]) of JNJ-61818549 and to evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a tablet (test) formulation in a crossover (method used to switch subjects from one study group to another in a clinical trial) design in healthy participants.

Conditions

Healthy

Keywords

Healthy; JNJ-42756493; JNJ-61818549; Isotope

Outcome Measures

Primary Outcomes (3)

• Relative Bioavailability: Maximum Plasma Concentration (Cmax)

  The Cmax is the maximum observed plasma concentration of JNJ-42756493.

  Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

• Absolute Bioavailability

  Absolute bioavailability will be measured by Area under concentration time-curve (AUC \[0-24\]), AUC (0-last) and AUC (0-infinity).

  Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

• Relative Bioavailability: Area under concententration time-curve (AUC)

  Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).

  Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

Secondary Outcomes (2)

• Time to Reach Maximum Concentration (tmax)

  Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

• Elimination Half-Life (t1/2)

  Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2.

Drug: JNJ-42756493 10 mg tablet; Drug: JNJ-42756493 10 mg Oral Solution; Drug: JNJ-61818549

Treatment Sequence BA

EXPERIMENTAL

Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2.

Drug: JNJ-42756493 10 mg tablet; Drug: JNJ-42756493 10 mg Oral Solution; Drug: JNJ-61818549

Interventions

JNJ-42756493 10 mg tablet DRUG

Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.

Treatment Sequence AB; Treatment Sequence BA

JNJ-42756493 10 mg Oral Solution DRUG

Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.

Treatment Sequence AB; Treatment Sequence BA

JNJ-61818549 DRUG

Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

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

You may qualify if:

• Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered an opportunity to participate by signing the separate pharmacogenomic informed consent document
• If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or surgically sterile
• If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
• Body mass index (BMI) (weight kilogram \[kg\]/ height square meter\[m\^2\] between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kg
• Non-smoker for at least 6 months before entering the study

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, metabolic bone disease (other than osteoporosis), infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
• Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed appropriate by the investigator
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

erdafitinib; Tablets; Solutions

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  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: August 14, 2014
• First Posted: August 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

BE (1)