AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects

A Phase I, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01114152

Enrollment

Registered

2010-04-30

Start date

2010-04-30

Completion date

2010-07-31

Last updated

2010-08-03

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

Conditions

Healthy

Keywords

AZD9742, Japanese Healthy Volunteers, Phase I, Single and Multiple Ascending Dose

Brief summary

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Interventions

DRUGAZD9742

IV Formulation

DRUGPlacebo

IV Formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

23 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* female (non-childbearing potential) * Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Design outcomes

Primary

Measure	Time frame
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)	collected prior to treatment, during treatment and follow-up for a total of 18-22 days

Secondary

Measure	Time frame
Characterize the Pharmacokinetics of AZD9742 in blood and urine	PK-sampling during 14 pre-defined study days for PK profiling

Countries

United States

Outcome results

None listed

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