A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult Participants

NCT02117505 | Completed Phase 1

• 2 other identifiers: CR10408854781532ARA1001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test) compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed conditions at a single dose of 150 milligram (mg).

Conditions

Healthy

Keywords

Biological Availability; JNJ-39220675; Healthy; Phase 1

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax) of JNJ-54781532

  The Cmax is the maximum observed plasma concentration.

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Time to Reach Maximum Concentration (tmax) of JNJ-54781532

  The tmax is time to reach the maximum observed plasma concentration.

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-54781532

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-54781532

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

Secondary Outcomes (6)

• Relative Bioavailability of JNJ-54781532

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Time to last quantifiable plasma concentration (tlast) of JNJ-54781532

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Area Under the Plasma Concentration Percentage (%) Extrapolation of JNJ-54781532

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Elimination Half-Life (t [1/2] Lambda) of JNJ-54781532

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

• Rate Constant (Lambda[z])

  Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

Study Arms (2)

Group 1 (Formulation 2 Then Formulation 1)

EXPERIMENTAL

Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in first treatment period; followed by JNJ-54781532 formulation 1 as 150 mg orally (5\*30 mg tablet=150 mg) in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: Formulation 2; Drug: Formulation 1

Group 2 (Formulation 1 Then Formulation 2)

EXPERIMENTAL

Single-dose of JNJ-54781532 formulation 1 will be administered as 150 mg oral tablet (5\*30 mg tablet=150 mg) in first treatment period; followed by JNJ-54781532 formulation 2 as 150 mg oral tablet in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: Formulation 2; Drug: Formulation 1

Interventions

Formulation 2 DRUG

Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.

Also known as: JNJ-54781532 Test

Group 1 (Formulation 2 Then Formulation 1); Group 2 (Formulation 1 Then Formulation 2)

Formulation 1 DRUG

Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5\*30 mg tablet=150 mg) in one of the treatment periods.

Also known as: JNJ-54781532 Reference

Group 1 (Formulation 2 Then Formulation 1); Group 2 (Formulation 1 Then Formulation 2)

Eligibility Criteria

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

You may qualify if:

• Female participants must be either: 1) not of childbearing potential: postmenopausal or surgically sterile at screening 2) of child-bearing potential: Must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening, and agree to use highly effective contraception throughout the study period, and for 90 days after final study drug administration. Women, who are not heterosexually active at Screening, must agree to utilize a highly-effective method of birth control if they become heterosexually active during their participation in the study
• Must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day (-)1 of Period 1
• Female participants must agree not to donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration
• If a 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 (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 90 days after receiving the last dose of study drug
• Participants eligible according to the following tuberculosis (TB) screening criteria: 1) following tuberculosis (TB) screening criteria 2) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination 3) have had no recent close contact with a person with active TB 4. Within 2 months prior to the first administration of study agent, have a negative T-spot or QuantiFERON-TB Gold test result

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, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection
• Participant had major gastrointestinal (GI) surgery
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day (-) 1 of Period 1
• Participant has an aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (\>=) the upper limit of normal (ULN)
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 1 year before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day (-) 1 of Period 1

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Akacid-medical-formulation

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: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

BE (1)