A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

• Sponsor: Avanir Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02174835
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 6
• Duration (Months): 2
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AVP-786; Drug: AVP-923	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A - Period 1 Twice daily dosing orally for 7 days	Drug: AVP-786
Active Comparator: Cohort A - Period 2 Twice daily dosing orally for 7 days	Drug: AVP-923
Experimental: Cohort A - Period 3 Twice daily dosing orally for 7 days	Drug: AVP-786
Experimental: Cohort B - Period 1 Twice daily dosing orally for 7 days	Drug: AVP-786
Active Comparator: Cohort B - Period 2 Twice daily dosing orally for 7 days	Drug: AVP-923
Experimental: Cohort B - Period 3 Twice daily dosing orally for 7 days	Drug: AVP-786

Outcome Measures

Primary Outcome Measures

1. Plasma concentrations of AVP-786 [7 days]

Secondary Outcome Measures

1. Incidence of adverse events (AEs) for AVP-786 [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adult males

• 18 - 45 years of age

• BMI 18 - 30 kg/m2

Exclusion Criteria:

• History or presence of significant disease

• History of substance abuse and/or alcohol abuse with the past 3 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX	Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

• Avanir Pharmaceuticals

Investigators

• Principal Investigator: Sepehr Shakib, M.D., CMAX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avanir Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02174835
• Other Study ID Numbers: 13-AVR-134
• First Posted: Jun 26, 2014
• Last Update Posted: Jun 26, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Avanir Pharmaceuticals: Pharmacokinetics; Healthy Volunteers; deuterated dextromethorphan; deuterated dextromethorphan with quinidine

Study Results

No Results Posted as of Jun 26, 2014