A Phase 1 Study Comparing AVP-786 With AVP-923

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336347
• Other study ID #: 14-AVP-786-102
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2015
• Last updated: July 10, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Avanir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adult males or females

• 18 - 60 years of age

• BMI 18 - 32 kg/m2

Exclusion Criteria:

• History or presence of significant disease

• History of substance abuse and/or alcohol abuse with the past 2 years

• Use of tobacco-containing or nicotine-containing products within 6 months

• Use of any prescription or the over-the-counter medications within 14 days

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AVP-786

• AVP-923

Locations

Country	Name	City	State
United States	Covance Dallas Clinical Research Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK of d6-DM in AVP-786 compared to DM in AVP-923		8 days	No
Secondary	PK of metabolites		8 days	No
Secondary	Safety and tolerability		8 days	Yes