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Completed

NCT Number: NCT02504463

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samidorphan IV

Drug

Single IV administration

[14c]-Samidorphan sublingual

Drug

Single sublingual administration containing radiolabel

[14c]-Samidorphan oral

Drug

Single oral administration containing radiolabel

Primary outcomes

  1. AUC 0-t

    Time frame: 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

  2. Cmax

    Time frame: Up to 120 hours after each dose

    Maximum concentration of total radioactivity in blood and plasma

  3. Tmax

    Time frame: Up to 120 hours after each dose

    Time to maximum concentration of total radioactivity in blood and plasma

  4. Fe%0-t

    Time frame: Up to 120 hours after each dose

    Fraction of dose excreted in urine and feces

Secondary outcomes

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

    Time frame: Up to 35 days

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2015
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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