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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Subject- And Investigator-blind, Sponsor-open, Placebo-controlled, Single- And Multiple-dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Cp-601,927 In Healthy Japanese Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01396135
• Other study ID #: A3331019
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 26, 2011
• Est. completion date: October 29, 2011

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 29, 2011
• Est. primary completion date: October 29, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female Japanese subjects between the ages of 18 and 55 years, inclusive.

• Japanese defined as being able to document that all 4 grandparents were Japanese and were born in Japan.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• 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 the time of dosing).

• Females of childbearing potential.

• Subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. Subjects with urine cotinine concentrations >100 ng/mL at any time during the study will be excluded.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CP-601,927
Single dose of 1 mg CP-601,927 given as oral 1 mg tablets
• CP-601,927
Single dose of 2 mg CP-601,927 given as oral 1 mg tablets
• CP-601,927
Single dose of 3 mg CP-601,927 given as oral 1 mg tablets
• Placebo
Single dose of placebo given as a matching number of oral tablets
• 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
• Placebo
Multiple doses of placebo given as a matching number of oral tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 1 mg CP-601,927		0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Primary	Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 2 mg CP-601,927		0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Primary	Cmax, AUClast, AUC0-12, Tmax and as data permit AUCinf, t1/2, CL/F, Vd/F after single dose of 3 mg CP-601,927		0,0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose
Primary	Ctrough, Cmax, AUC0-12, Tmax and as data permit t1/2, CL/F and Rac (accumulation ratio) based on Cmax and AUC0-12 after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days		Day1-7
Primary	Suicidality assessment after single dose of 1 mg CP-601,927		Day 0, 0 and 2 hours post-dose
Primary	Suicidality assessment after single dose of 2 mg CP-601,927		Day 0, 0 and 2 hours post-dose
Primary	Suicidality assessment after single dose of 3 mg CP-601,927		Day 0, 0 and 2 hours post-dose
Primary	Suicidality assessment after multiple doses of CP-601,927 given as 2 mg BID (4mg/day) for 7 days		Day1-7

External Links

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