Safety, PK and PD Study in Healthy Male Japanese Subjects

Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sca-136 Administered Orally to Healthy Male Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447941

Enrollment

Registered

2007-03-15

Start date

2006-06-30

Completion date

2006-08-31

Last updated

2009-08-07

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

Conditions

Schizophrenia

Brief summary

Study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of SCA-136 in healthy male Japanese subjects

Interventions

DRUGSCA-136

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Men aged 20 to 45 years at the time of obtaining informed consent. * Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg. * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria

* Presence or history of any disorder that may prevent the successful completion of the study. * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (ADME) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).

Design outcomes

Primary

Measure	Time frame
safety and tolerability	—

Outcome results

None listed

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