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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AVP-786; Drug: AVP-923

• Registration Number: NCT02336347
• Lead Sponsor: Avanir Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-09
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Study Completion: 2015-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 - Period 2	AVP-786	Twice daily dosing of AVP-786 orally for 8 days
Group 1 - Period 1	AVP-786	Twice daily dosing of AVP-786 orally for 8 days
Group 1 - Period 2	AVP-923	Twice daily dosing of AVP-923 orally for 8 days
Group 2 - Period 1	AVP-923	Twice daily dosing of AVP-923 orally for 8 days

Primary Outcome Measures

Name	Time	Method
PK of d6-DM in AVP-786 compared to DM in AVP-923	8 days

Secondary Outcome Measures

Name	Time	Method
PK of metabolites	8 days
Safety and tolerability	8 days

Trial Locations

Locations (1)

Covance Dallas Clinical Research Unit; 🇺🇸 Dallas, Texas, United States