Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089295

B4501035

Details and patient eligibility

About

To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between 18 and 55 years of age

Exclusion criteria

• Evidence or history of clinically significant disease.
• Positive urine drug test

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment B

Experimental group

Description:

Single dose of 20 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment C

Experimental group

Description:

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone