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OpenTrials
Completed

NCT Number: NCT01787747

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

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CMAX

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-786 Dose 1

Drug

AVP-786 Dose 2

Drug

AVP-786 Dose 1/Q Dose 1

Drug

AVP-786 Dose 1/Q Dose 2

Drug

AVP-786 Dose 2/Q Dose 2

Drug

AVP-923

Drug

Primary outcomes

  1. Plasma concentrations of parent and metabolites

    Time frame: 8 Days

Secondary outcomes

  1. Safety and tolerability

    Time frame: 8 days

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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-center, Randomized, Double-blind, Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Doses of AVP-786 (Deuterated Dextromethorphan) in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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