ALK33-001: A Study of RDC-0313 Administered to Healthy Adults

Alkermes

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: RDC-0313; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800319

ALK33-001

Details and patient eligibility

About

The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.

Full description

This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 - 65 years of age
• Body mass index of 19-30 kg/m2 at screening
• If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
• If subject is male, he must agree to reduce the risk of a female partner becoming pregnant

Exclusion criteria

• Pregnancy and/or currently breastfeeding
• Clinically significant medical condition or observed abnormalities
• Clinically significant illness within 30 days of the first study drug administration
• History of opioid dependence
• Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
• Positive resolut for any serology test performed at screening
• Use of alcohol-, caffeine-, or xanthine-containing products
• Tobacco use within 90 days before the first study drug administration
• Participation in a clinical trial within 30 days before screening
• Requirement of a special diet other than vegetarian, or significant food allergy or intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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16 participants in 6 patient groups, including a placebo group

RDC-0313, 5mg

Experimental group

Description:

5 mg of RDC-0313; single dose

Treatment:

Drug: RDC-0313

RDC-0313, 15 mg

Experimental group

Description:

15 mg RDC-0313; single dose

Treatment:

Drug: RDC-0313

RDC-0313, 25mg

Experimental group

Description:

25 mg RDC-0313; single dose

Treatment:

Drug: RDC-0313

RDC-0313, 50 mg

Experimental group

Description:

50 mg RDC-0313; single dose

Treatment:

Drug: RDC-0313

RDC-0313, 75 mg

Experimental group

Description:

75 mg RDC-0313; single dose

Treatment:

Drug: RDC-0313

Placebo

Placebo Comparator group

Description:

volume-match placebo; single dose

Treatment:

Drug: Placebo