A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers

Sponsor

Alkermes, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02504463

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the pharmacokinetics (PK) of [14c]-samidorphan in healthy male volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Samidorphan IV Drug: [14c]-Samidorphan sublingual Drug: [14c]-Samidorphan oral	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-Center, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of Single Doses of [14c]-Samidorphan in Healthy Male Subjects

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Samidorphan IV Samidorphan solution for IV administration	Drug: Samidorphan IV Single IV administration
Experimental: Samidorphan sublingual [14c]-Samidorphan for sublingual administration	Drug: [14c]-Samidorphan sublingual Single sublingual administration containing radiolabel
Experimental: Samidorphan oral [14c]-Samidorphan for oral administration	Drug: [14c]-Samidorphan oral Single oral administration containing radiolabel

Arm

Intervention/Treatment

Experimental: Samidorphan IV

Samidorphan solution for IV administration

Drug: Samidorphan IV

Single IV administration

Experimental: Samidorphan sublingual

[14c]-Samidorphan for sublingual administration

Drug: [14c]-Samidorphan sublingual

Single sublingual administration containing radiolabel

Experimental: Samidorphan oral

[14c]-Samidorphan for oral administration

Drug: [14c]-Samidorphan oral

Single oral administration containing radiolabel

Outcome Measures

Primary Outcome Measures

AUC 0-t [Up to 120 hours after each dose]
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Cmax [Up to 120 hours after each dose]
Maximum concentration of total radioactivity in blood and plasma
Tmax [Up to 120 hours after each dose]
Time to maximum concentration of total radioactivity in blood and plasma
Fe%0-t [Up to 120 hours after each dose]
Fraction of dose excreted in urine and feces

Secondary Outcome Measures

Safety and tolerability will be measured by the incidence of Adverse Events [Up to 35 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m^2 at screening (minimum weight of 50.0 kg)
Generally good health
Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last dose of the study drug by abstinence from heterosexual relationships or use of a reliable contraceptive method
Additional criteria may apply

Exclusion Criteria:

Clinically significant illness within 30 days
History of alcohol or opioid dependence, or positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
History of oral or gastrointestinal disease
Irregular bowel or bladder function
History of allergy or hypersensitivity to opioid medications or opioid antagonists (eg, naltrexone, naloxone)
Current or pending legal charges or probation that would interfere with study conduct
Use of alcohol within 24 hours prior to admission or urine positive test for alcohol at screening or admission
Tobacco or nicotine use within 90 days
Anticipated need for prescription medicines during the study period
Additional criteria may apply