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

NCT02504463 | Completed Phase 1

• 1 other identifier: ALK33-B107
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Alkermes; Samidorphan; ALKS 33; Healthy Volunteer; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• AUC 0-t

  Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma

  Up to 120 hours after each dose

• Cmax

  Maximum concentration of total radioactivity in blood and plasma

  Up to 120 hours after each dose

• Tmax

  Time to maximum concentration of total radioactivity in blood and plasma

  Up to 120 hours after each dose

• Fe%0-t

  Fraction of dose excreted in urine and feces

  Up to 120 hours after each dose

Secondary Outcomes (1)

• Safety and tolerability will be measured by the incidence of Adverse Events

  Up to 35 days

Study Arms (3)

Samidorphan IV

EXPERIMENTAL

Samidorphan solution for IV administration

Drug: Samidorphan IV

Samidorphan sublingual

EXPERIMENTAL

\[14c\]-Samidorphan for sublingual administration

Drug: [14c]-Samidorphan sublingual

Samidorphan oral

EXPERIMENTAL

\[14c\]-Samidorphan for oral administration

Drug: [14c]-Samidorphan oral

Interventions

Samidorphan IV DRUG

Single IV administration

Samidorphan IV

[14c]-Samidorphan sublingual DRUG

Single sublingual administration containing radiolabel

Samidorphan sublingual

[14c]-Samidorphan oral DRUG

Single oral administration containing radiolabel

Samidorphan oral

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigational Site

Austin, Texas, 78744, United States

Location

Study Officials

• Arielle Stanford, MD

  Alkermes Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 22, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)