Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01217918

Enrollment

Registered

2010-10-08

Start date

2010-10-31

Completion date

2011-02-28

Last updated

2011-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PH-797804, Japanese, Phase 1, multiple dose study

Brief summary

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

Interventions

DRUG1 mg

1 mg or placebo a material sparing tablet per day for 10 days

DRUG5 mg

5 mg or placebo as material sparing tablet per day for 10 days

DRUG10 mg

10 mg or placebo as a material sparing tablet per day for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Volunteers * Japanese

Exclusion criteria

* Subjects with clinically significant skin lesions * Subjects with known tuberculosis infection

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.	Day 1 to Follow-up
Mean change from baseline in vital signs (blood pressure and heart rate) measurements	Baseline to Follow-up
Mean change from baseline in 12-lead ECG parameters	Baseline to Follow-up
Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax	Days 1 and 10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026