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

Avanir Pharmaceuticals56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AVP-786DRUG

AVP-923DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CMAX

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Plasma concentrations of AVP-786

Time frame: 7 days

Secondary Outcomes

Incidence of adverse events (AEs) for AVP-786

Time frame: 7 days

Data from ClinicalTrials.gov

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