JNJ-38877618: Part 1a - Healthy Volunteers | Phase 1 | Johnson & Johnson | BiopharmaWatch

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JNJ-38877618: Part 1a

Phase 1

Healthy Volunteers | Small molecule | Other |Johnson & Johnson|Last Updated: Sep 12, 2014

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker

Total Trials1

Total Enrollment84

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT01964872	A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants	PHASE1	COMPLETED	84	—	—	Nov 1, 2013	May 1, 2014	Sep 12, 2014	1	United Kingdom

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Study Endpoints

Primary Endpoints

Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)

Up to 30 days after the last dose of study medication

Time to reach the maximum observed plasma concentration of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Elimination half-life of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

First-order rate constant associated with the terminal portion of the curve of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Total clearance of drug after oral administration of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Apparent volume of distribution after oral administration of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 4 Day 2)

Maximum observed plasma concentration during a dosing interval at steady state of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Minimum observed plasma concentration during a dosing interval at steady state of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Average plasma concentration over the dosing interval at steady state of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Trough observed plasma concentration at the end of dosing interval of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Area under the plasma concentration-time curve during a dosing interval of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Area under the plasma concentration-time curve during a dosing interval at steady-state of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Accumulation index of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Apparent volume of distribution at steady-state after oral administration of JNJ-38877618

Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

Secondary Endpoints

Maximum tolerated dose of JNJ-38877618

Up to 30 days after last dose of study medication (up to Part 2)

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
JNJ-38877618	EXPERIMENTAL	-
Placebo	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
JNJ-38877618: Part 1a	DRUG	Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 1b	DRUG	Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 1c (optional)	DRUG	Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 2	DRUG	Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
JNJ-38877618: Part 3	DRUG	Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
JNJ-38877618: Part 4 (optional)	DRUG	Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.
Placebo: Parts 1a, 2, 3, and 4 (optional)	DRUG	Administered orally matched to study drug

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Eligibility Criteria

Age Range18 Years — 65 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1 * Must have good exercise tolerance * Agrees to protocol-defined use of effec...

Countries:United Kingdom

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