Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers

Phase 1CompletedNCT01787747

Avanir Pharmaceuticals48 enrolled

Overview

To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AVP-786 Dose 1DRUG

AVP-786 Dose 2DRUG

AVP-786 Dose 1/Q Dose 1DRUG

AVP-786 Dose 1/Q Dose 2DRUG

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 and/or alcohol abuse within the past 3 years * Use of tobacco-containing or nicotine-contining products within 6 months * Use of any prescription of over-the-counter (OTC) medication within 14 days

Locations (1)

CMAX

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Plasma concentrations of parent and metabolites

Time frame: 8 Days

Secondary Outcomes

Safety and tolerability

Assessments to include Physical Examination (PE), Labs, ECGs, and Adverse Events (AEs)

Time frame: 8 days

Data from ClinicalTrials.gov

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