Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Substance-Related Disorders Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046539
• Other study ID #: ALK33-008
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: January 10, 2017
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject must be capable of understanding and complying with the protocol and has signed the informed consent

• Must be 18-55 years of age

• Must have a body mass index of 18.0-30.0 kg/m2 at screening

• Female subjects must agree to use an acceptable method of contraception from date of consent and until two weeks after the last dose

• Subjects must be willing not to use alcohol-, tobacco, caffeine-, or xanthine-containing products while resident at inpatient facility

• Subjects must be an experienced opioid user who meets the following criteria: 1) has used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions in the past five years; 2) has used opioids at least 2 times in the two years prior to screening; and 3) is not physically dependent on opioids, as assessed by medical history and naloxone challenge performed at screening

Exclusion Criteria:

• Must not have any current or piror significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders.

• Must not have current or past opioid, alcohol, or other durg dependence (excluding nicotine and caffeine) or showing signs of withdrawal following the naloxone (Narcan) challenge.

• Please contact site for additional information about other exclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Drug:
• RDC-0313 + Buprenorphine
1 and 4 mg (1 dose for each) + 8 mg
• Placebo
0 mg

Locations

Country	Name	City	State
United States	Langley Porter Psychiatric Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics (PD) of study drug		24 hour period	Yes
Primary	VAS Scores		24 Hours period	Yes
Primary	Pupuillometry Assessments		24 Hour Period	Yes
Primary	Subjective Symptoms		15 min pre and post nal, 3 hrs post bup admin	Yes
Secondary	To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug		24 hour period	Yes
Secondary	Max plasma concentration		24 Hour Period	Yes
Secondary	Time to maximum plasma concentration		24 Hour Period	Yes
Secondary	Area under the concentration time curve (AUC)		24 Hour Period	Yes
Secondary	Additional PK parameters may be analyzed		As appropriate	Yes