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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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