A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers

NCT01959594 | Completed Phase 1

• 1 other identifier: B7441002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days

Conditions

Healthy

Keywords

multiple doses; pharmacokinetics; safety; tolerability; healthy volunteers; steady state; cognitive impairment associated with schizophrenia

Outcome Measures

Primary Outcomes (3)

• Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS.

  0-15 days

• Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR,

  0-15 days

• CogState at followup

  22-25 days

Study Arms (5)

Cohort 1

EXPERIMENTAL

Drug: 3 mg PF-06412562

Cohort 2

EXPERIMENTAL

Drug: 10 mg PF-06412562

Cohort 3

EXPERIMENTAL

Drug: 25 mg PF-06412562

Optional Cohort 4

EXPERIMENTAL

Drug: PF-06412562 TBD mg

Optional Cohort 5

EXPERIMENTAL

Drug: PF-06412562 TBD mg

Interventions

3 mg PF-06412562 DRUG

oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days

Cohort 1

10 mg PF-06412562 DRUG

oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days

Cohort 2

25 mg PF-06412562 DRUG

oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days

Cohort 3

PF-06412562 TBD mg DRUG

oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts

Optional Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

US (1)