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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01002625
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep; Healthy Volunteers	Drug: PF-04457845 / matched placebo; Drug: PF-04457845 / matched placebo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects Of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. PF-04457845 followed by placebo PF-04457845 followed by placebo	Drug: PF-04457845 / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo
Experimental: 2. Placebo followed by PF-04457845 Placebo followed by PF-04457845	Drug: PF-04457845 / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo

Outcome Measures

Primary Outcome Measures

1. Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100). [3 days]

Secondary Outcome Measures

1. Percentage of total sleep time spent in Stage 1 sleep [3 days]

2. Percentage of total sleep time spent in Stage 2 sleep [3 days]

3. Percentage of total sleep time spent in Stage 3-4 sleep [3 days]

4. Total sleep time [3 days]

5. Sleep efficiency (total sleep time/time in bed * 100). [3 days]

6. Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO). [3 days]

7. Number of arousals after sleep onset (NASO [3 days]

8. Latency to persistent sleep [3 days]

9. Plasma concentrations of PF-04457845. [3 days]

10. Plasma concentrations of fatty acid amides. [3 days]

11. Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG. [3 days]

12. Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG. [3 days]

13. Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep. [3 days]

14. For definitions of polysomnography variable objectives and endpoints see Appendix 3 [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New York	New York	United States	10019

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01002625
• Other Study ID Numbers: B0541008
• First Posted: Oct 27, 2009
• Last Update Posted: Jul 8, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Double-Blind Randomized Placebo-Controlled 2-Way Crossover Polysomnographic Endpoints

Study Results

No Results Posted as of Jul 8, 2010