Trial | NCT01787747  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.
Study Started
Oct 31
2012
Primary Completion
Feb 28
2013
Study Completion
Feb 28
2013
Last Update
Jun 26
2014
Estimate

Drug 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

Cohorts A and C Experimental

Single dose (D1) followed by twice daily dosing for 7 days

Cohorts B and D Experimental

Single dose (D1) followed by twice daily dosing for 7 days

Cohorts E and F Experimental

Single dose (D1) followed by twice daily dosing for 7 days

Cohorts G and I Experimental

Single dose (D1) followed by twice daily dosing for 7 days

Cohorts H and J Experimental

Single dose (D1) followed by twice daily dosing for 7 days

Criteria 

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
No Results Posted