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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Drug-drug Interaction

Treatments: Drug: Paroxetine; Drug: Duloxetine; Drug: AVP-786

Study type: Interventional

Funder types: Industry

Identifiers

NCT02174822

14-AVP-786-101

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Paroxetine + AVP-786

Experimental group

Description:

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

Treatment:

Drug: AVP-786

Drug: Paroxetine

AVP-786 + paroxetine

Experimental group

Description:

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

Treatment:

Drug: AVP-786

Drug: Paroxetine

Duloxetine + AVP-786

Experimental group

Description:

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

Treatment:

Drug: AVP-786

Drug: Duloxetine

AVP-786 + duloxetine

Experimental group

Description:

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

Treatment:

Drug: AVP-786

Drug: Duloxetine