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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01787747
Enrollment
48
Registered
2013-02-11
Start date
2012-10-01
Completion date
2013-02-01
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Healthy Volunteers, dextromethorphan with quinidine, deuterated dextromethorphan

Brief summary

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

Interventions

DRUGAVP-786 Dose 1
DRUGAVP-786 Dose 2
DRUGAVP-786 Dose 1/Q Dose 1
DRUGAVP-786 Dose 1/Q Dose 2
DRUGAVP-786 Dose 2/Q Dose 2
DRUGAVP-923

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
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 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

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of parent and metabolites8 Days

Secondary

MeasureTime frameDescription
Safety and tolerability8 daysAssessments to include Physical Examination (PE), Labs, ECGs, and Adverse Events (AEs)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026