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

Avanir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AVP-786 Dose 2/Q Dose 2; Drug: AVP-786 Dose 1/Q Dose 2; Drug: AVP-923; Drug: AVP-786 Dose 2; Drug: AVP-786 Dose 1/Q Dose 1; Drug: AVP-786 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01787747

12-AVR-132

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

48 participants in 5 patient groups

Cohorts A and C

Experimental group

Description:

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

Treatment:

Drug: AVP-786 Dose 1

Drug: AVP-923

Cohorts B and D

Experimental group

Description:

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

Treatment:

Drug: AVP-786 Dose 2

Drug: AVP-923

Cohorts E and F

Experimental group

Description:

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

Treatment:

Drug: AVP-786 Dose 1/Q Dose 1

Drug: AVP-923

Cohorts G and I

Experimental group

Description:

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

Treatment:

Drug: AVP-923

Drug: AVP-786 Dose 1/Q Dose 2

Cohorts H and J

Experimental group

Description:

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

Treatment:

Drug: AVP-923

Drug: AVP-786 Dose 2/Q Dose 2