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

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

Detailed Description
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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.

Official Title
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ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: RDC-0313
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDC-0313, 5mg<br>5 mg of RDC-0313; single dose | Drug: RDC-0313<br>* Oral solution given in 5, 15, 25, 50, and 75 mg single doses<br>|
| Experimental: RDC-0313, 15 mg<br>15 mg RDC-0313; single dose | Drug: RDC-0313<br>* Oral solution given in 5, 15, 25, 50, and 75 mg single doses<br>|
| Experimental: RDC-0313, 25mg<br>25 mg RDC-0313; single dose | Drug: RDC-0313<br>* Oral solution given in 5, 15, 25, 50, and 75 mg single doses<br>|
| Experimental: RDC-0313, 50 mg<br>50 mg RDC-0313; single dose | Drug: RDC-0313<br>* Oral solution given in 5, 15, 25, 50, and 75 mg single doses<br>|
| Experimental: RDC-0313, 75 mg<br>75 mg RDC-0313; single dose | Drug: RDC-0313<br>* Oral solution given in 5, 15, 25, 50, and 75 mg single doses<br>|
| Placebo Comparator: Placebo<br>volume-match placebo; single dose | Drug: Placebo<br>* Volume matched placebo; oral solution; single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentrations (Cmax) of RDC-0313 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically significant abnormal laboratory findings |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol dependence, Opioid antagonist, RDC-0313