A Study of ALKS 5461 in Healthy Volunteers

Alkermes

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Placebo; Drug: ALKS 5461

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068105

ALK5461-209

Details and patient eligibility

About

This is a study to test the safety of ALKS 5461 in healthy adults.

Enrollment: 104 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be in good physical health
• Body mass index of 18-30 kg/m2
• Agree to use an approved method of birth control for the duration of the study
• Additional criteria may apply

Exclusion criteria

• Currently pregnant or breastfeeding
• History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
• Current or history of any clinically significant medical or psychiatric condition
• Current abuse or dependence on alcohol or any illicit drugs
• Have used nicotine within 90 days
• Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
• Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
• Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
• Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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104 participants in 6 patient groups, including a placebo group

ALKS 5461-A

Experimental group

Treatment:

Drug: ALKS 5461

ALKS 5461-B

Experimental group

Treatment:

Drug: ALKS 5461

ALKS 5461 Dose 1

Experimental group

Treatment:

Drug: ALKS 5461

ALKS 5461 Dose 2

Experimental group

Treatment:

Drug: ALKS 5461

ALKS 5461 Dose 3

Experimental group

Treatment:

Drug: ALKS 5461

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo