Scopolamine Challenge Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Scopolamine; Drug: Donepezil; Drug: Placebo; Drug: scopolamine; Drug: PF-05212377

Study type: Interventional

Funder types: Industry

Identifiers

NCT01213355

B2081009

Details and patient eligibility

About

It is hypothesized that PF-05212377 (SAM-760) will reverse scopolamine induced cognitive impairments in healthy adults subjects.

Full description

Proof of mechanism

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive.
• Body Mass index (BMI) of between 17.5 to 30.5 kg/m2 inclusive; and a total body weight greater than or equal to 50 kg (110 lbs).

Exclusion criteria

• Presence or history of any disorder that may prevent the successful completion of the study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 5 patient groups

Placebo

Experimental group

Description:

placebo, plus scopolamine 0.5 mg

Treatment:

Drug: Scopolamine

Drug: Scopolamine

Drug: Scopolamine

Drug: Placebo

PF-05212377 5 mg, plus scopolamine 0.5 mg;

Experimental group

Treatment:

Drug: Scopolamine

Drug: PF-05212377

Drug: PF-05212377

Drug: PF-05212377

Drug: Scopolamine

Drug: Scopolamine

PF-05212377 20 mg, plus scopolamine 0.5 mg;

Experimental group

Treatment:

Drug: scopolamine

Drug: PF-05212377

Drug: PF-05212377

Drug: PF-05212377

Drug: scopolamine

PF-05212377 60 mg, plus scopolamine 0.5 mg;

Experimental group

Treatment:

Drug: scopolamine

Drug: PF-05212377

Drug: PF-05212377

Drug: PF-05212377

Drug: scopolamine

donepezil 10 mg, plus scopolamine 0.5 mg.

Active Comparator group

Treatment:

Drug: Scopolamine

Drug: Scopolamine

Drug: Scopolamine

Drug: Donepezil