A Phase 1 interventional study of JNJ-42756493 Current Clinical Formulation (G-018) and JNJ-42756493 Prototype Formulation I (G-025) in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Other
The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.
This is an open-label (all people know the identity of the intervention), multi-period, randomized (study drug assigned by chance), single-dose, 3-way crossover study. The study consists of 21-day screening period, 3 open-label treatment periods with a minimum 21 (+-2)-day washout between doses, and end-of-study assessments 10 (+-2) days after the last dose. The duration of study is approximately 3 months. Participants will be randomized to 1 of 6 treatment sequences as follows: Treatment sequence 1=ABC, 2=BCA, 3=CAB, 4=ACB, 5=BAC AND 6=CBA. Treatment A=JNJ-42756493 current clinical formulation, 10 milligrams (mg) (2 tablets of 5 mg each). Treatment B= JNJ-42756493 Prototype Formulation I (G-025), 10 mg (2 tablets of 5 mg each) and Treatment C=JNJ-42756493 Prototype Formulation II (G-025), 10 mg (2 tablets of 5 mg each). Blood samples will be collected to determine pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
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Exclusion Criteria:
Participants will receive treatment A (JNJ-42756493 10 milligram \[mg\] tablet, current clinical formulation \[G-018\] which uses milled active pharmaceutical ingredient \[API\]) in period 1, treatment B (JNJ-42756493 10 mg tablet, Prototype Formulation I \[G-025\] which uses coarser API) in period 2 and then treatment C (JNJ-42756493 10 mg tablet, Prototype Formulation II \[G-025\] which uses coarser API) in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3.
Drug: JNJ-42756493 Current Clinical Formulation (G-018) · Drug: JNJ-42756493 Prototype Formulation I (G-025) · Drug: JNJ-42756493 Prototype Formulation II (G-025)
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493
The Cmax is the maximum observed plasma JNJ-42756493 concentration. Relative bioavailability will be calculated by Cmax based on total drug concentrations.
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24]) of JNJ-42756493
AUC(0-24) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to 24 hours. Relative bioavailability will be calculated by AUC(0-24) based on total drug concentrations.
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (Clast) (AUC[0-last]) of JNJ-42756493
AUC(0-last) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast). Relative bioavailability will be calculated by AUC(0-last) based on total drug concentrations.
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time AUC (infinity) of JNJ-42756493
AUC (infinity) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(0-last) and Clast/lambda(z), in which lambda(z) is the first-order rate constant associated with the terminal portion of the curve. Relative bioavailability will be calculated by AUC (infinity) based on total drug concentrations.
Time frame: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to end of study (up to 3 months)
The record gives a start of Jun 2015, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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