Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants

NCT02231489 | Completed Phase 1

• 3 other identifiers: CR10526942756493EDI10032014-002635-33
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral dose of capsule (reference) versus tablet (test) in healthy participants.

Conditions

Healthy

Keywords

Healthy; JNJ-42756493; JNJ-61818549

Outcome Measures

Primary Outcomes (2)

• Absolute Bioavailability (F[abs]) of JNJ-42756493

  The F (abs) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC \[0-infinity\] for test)/(AUC \[0-infinity\] for reference \[ref\])\*(D for ref/D for test )\*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.

  Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2

• Relative Bioavailability (F[rel]) of JNJ-42756493

  The F (rel) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC \[0-infinity\] for test)/(AUC \[0-infinity\] for reference \[ref\])\*(D for test/D for ref )\*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.

  Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of JNJ-42756493

  Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2

• Time to Reach Maximum Concentration (tmax)

  Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2

• Elimination Half-Life (t [1/2] Lambda)

  Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

Participants will receive treatment A (JNJ-42756493 tablet 10 milligram \[mg\] as single oral dose) along with JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 tablet on Day 1 in Treatment Period 1. Participants will receive treatment B (JNJ-42756493 capsule 10 mg as single oral dose) on Day 1 of Treatment Period 2.

Drug: JNJ-42756493 Tablet; Drug: JNJ-42756493 Capsule; Drug: JNJ-61818549

Treatment Sequence BA

EXPERIMENTAL

Participants will receive treatment B (JNJ-42756493 capsule 10 mg as single oral dose) along with 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 capsule on Day 1 in Treatment Period 1. Participants will receive treatment A (JNJ-42756493 tablet as single oral dose) on Day 1 of Treatment Period 2.

Drug: JNJ-42756493 Tablet; Drug: JNJ-42756493 Capsule; Drug: JNJ-61818549

Interventions

JNJ-42756493 Tablet DRUG

Participants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.

Treatment Sequence AB; Treatment Sequence BA

JNJ-42756493 Capsule DRUG

Participants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.

Treatment Sequence AB; Treatment Sequence BA

JNJ-61818549 DRUG

Participants will JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment 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:

• Participants who have 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
• Female participants must be postmenopausal (no spontaneous menses for at least 2 years, or surgically sterile and must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening
• Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Participant must have body mass index (BMI) (weight \[kilogram {kg}\]/height\^2 \[m\^2\]) between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kg
• Participants must be non-smoker for at least 6 months before entering the study

You may not qualify if:

• Participants with a 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, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Participants with history or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
• Participants with the 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
• Participants with positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at screening and on Day-1 of the first treatment period

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

erdafitinib

Study Officials

• Janssen Research & Development, LLC Clinical Trials

  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: September 1, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

BE (1)