Trial Outcomes & Findings for A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects (NCT NCT02679469)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

Results posted on

2017-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Nalmefene Hydrochloride 10 mg nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nalmefene Hydrochloride 10 mg n=7 Participants nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	21.6 years STANDARD_DEVIATION 0.8 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Region of Enrollment Japan	7 participants n=93 Participants

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

Outcome measures

Outcome measures
Measure	Nalmefene Hydrochloride 10 mg n=7 Participants nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)	8.88 ng/mL Standard Deviation 3.34

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

Outcome measures

Outcome measures
Measure	Nalmefene Hydrochloride 10 mg n=7 Participants nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)	61.8 ng･h/mL Standard Deviation 18.0

PRIMARY outcome

Timeframe: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

Outcome measures

Outcome measures
Measure	Nalmefene Hydrochloride 10 mg n=7 Participants nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Measure the Terminal-phase Elimination Half-life (T1/2)	12.1 hours Interval 8.7 to 14.7

Adverse Events

Nalmefene Hydrochloride 10 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nalmefene Hydrochloride 10 mg n=7 participants at risk nalmefene 10 mg tablet nalmefene hydrochloride 10 mg
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • From consent acquisition until 5 days after administration of Investigational Medicinal Product
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • From consent acquisition until 5 days after administration of Investigational Medicinal Product

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., Ltd.

Phone: +81-3-6361-7366

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place