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A Phase 1 Study To Investigate The Pharmacokinetics, Safety And Tolerability Of CP-601,927 In Healthy Japanese Subjects

NCT01396135 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-10-30

No results posted yet for this study

Summary

This Phase 1 study is the first clinical trial to be conducted in Japanese subjects. The pharmacokinetics, safety and tolerability of single and multiple doses of CP-601,927 will be evaluated in Japanese, healthy, non-smoking subjects.

Conditions

  • Healthy

Interventions

DRUG

CP-601,927

Single dose of 1 mg CP-601,927 given as oral 1 mg tablets

DRUG

CP-601,927

Single dose of 2 mg CP-601,927 given as oral 1 mg tablets

DRUG

CP-601,927

Single dose of 3 mg CP-601,927 given as oral 1 mg tablets

DRUG

Placebo

Single dose of placebo given as a matching number of oral tablets

DRUG

CP-601,927

Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days

DRUG

Placebo

Multiple doses of placebo given as a matching number of oral tablets

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-26
Primary Completion
2011-10-29
Completion
2011-10-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396135 on ClinicalTrials.gov