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

August 19, 2011 updated by: Alkermes, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles Phase One Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically significant abnormal laboratory findings
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Principal Investigator: Philip T. Leese, MD, Quintiles Phase One Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 1, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 2008

Study Record Updates

Last Update Posted (Estimate)

August 22, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK33-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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