A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers; Sleep

Treatments: Drug: PF-04457845 / matched placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002625

B0541008

Details and patient eligibility

About

PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.

Full description

The trial was terminated prematurely December 3, 2009 owing to an operational error. There were no safety or efficacy concerns relating to the study and the decision to terminate the trial.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects between the ages of 18 and 55 years Body Mass Index (BMI) between 17.5 and 30.5 kg/m2; and a total body weight >50 kg

Exclusion criteria

• History of any active sleep disorder.
• History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years.
• Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

18 participants in 2 patient groups

1. PF-04457845 followed by placebo

Experimental group

Description:

PF-04457845 followed by placebo

Treatment:

Drug: PF-04457845 / matched placebo

Drug: PF-04457845 / matched placebo

2. Placebo followed by PF-04457845

Experimental group

Description:

Placebo followed by PF-04457845

Treatment:

Drug: PF-04457845 / matched placebo

Drug: PF-04457845 / matched placebo