A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02174822
Collaborator
(none)
56
1
4
3
18.9

Study Details

Study Description

Brief Summary

To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paroxetine + AVP-786

Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20.

Drug: AVP-786

Drug: Paroxetine

Experimental: AVP-786 + paroxetine

AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20

Drug: AVP-786

Drug: Paroxetine

Experimental: Duloxetine + AVP-786

Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13.

Drug: AVP-786

Drug: Duloxetine

Experimental: AVP-786 + duloxetine

AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13.

Drug: AVP-786

Drug: Duloxetine

Outcome Measures

Primary Outcome Measures

  1. Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects [20 days]

  2. Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine. [20 days]

  3. Change in plasma concentration of duloxetine after combined dosing with AVP-786 [13 days]

  4. Change in plasma concentration of AVP-786 after combined dosing with duloxetine. [13 days]

Secondary Outcome Measures

  1. Incidence of adverse events (AEs) for AVP-786 and paroxetine [20 days]

  2. Incidence of adverse events (AEs) for AVP-786 and duloxetine [13 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adult males and females

  • 18 - 50 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nucleus Network Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Principal Investigator: Jason Lickliter, MBBS PhD FRACP, Nucleus Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT02174822
Other Study ID Numbers:
  • 14-AVP-786-101
First Posted:
Jun 26, 2014
Last Update Posted:
Feb 18, 2022
Last Verified:
Jun 1, 2014
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022