A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-42756493 Prototype Formulation II (G-025); Drug: JNJ-42756493 Current Clinical Formulation (G-018); Drug: JNJ-42756493 Prototype Formulation I (G-025)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02466815

42756493EDI1004 (Other Identifier)

2015-001583-19 (EudraCT Number)

CR107460

Details and patient eligibility

About

The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants should be willing to adhere to the prohibitions and restrictions specified in this protocol
• Woman must be either: postmenopausal (greater than (>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (follicle stimulating hormone [FSH]) >40 international unit per litre [IU/L]); surgically sterile
• Woman must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
• Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug.
• Man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion criteria

• Participants with 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, or any other illness that the investigator considers should exclude the subject 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 clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
• Participants with clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
• Participants with 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 until completion of the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

Treatment A, then Treatment B and then Treatment C

Experimental group

Description:

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.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Treatment B, then Treatment C and then Treatment A

Experimental group

Description:

Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Treatment C, then Treatment A and then Treatment B

Experimental group

Description:

Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Treatment A, then Treatment C and then Treatment B

Experimental group

Description:

Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Treatment B, then Treatment A and then Treatment C

Experimental group

Description:

Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)

Treatment C, then Treatment B and then Treatment A

Experimental group

Description:

Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3.

Treatment:

Drug: JNJ-42756493 Prototype Formulation I (G-025)

Drug: JNJ-42756493 Current Clinical Formulation (G-018)

Drug: JNJ-42756493 Prototype Formulation II (G-025)