A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00434785

Enrollment

Unknown

Registered

2007-02-13

Start date

2007-02-28

Completion date

2007-09-30

Last updated

2007-12-05

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

Conditions

Healthy

Brief summary

To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.

Interventions

DRUGAGG-523

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration. * Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight \>45 kg. * Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.

Design outcomes

Primary

Measure	Time frame
To assess the safety and PK profile	—

Countries

Japan

Outcome results

None listed

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