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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes