AZD7325 Multiple Ascending Dose Study

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681915

Acronym

MAD

Enrollment

Registered

2008-05-21

Start date

2008-03-31

Completion date

2008-07-31

Last updated

2010-12-09

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

Conditions

Healthy Volunteer

Keywords

Phase I, Pharmacokinetics

Brief summary

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

Interventions

DRUGAZD7325

Oral

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Female subjects must be of non-child bearing potential.

Exclusion criteria

* Clinically significant illness within 2 weeks before the study start. * Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit * Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2 * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs	Alssessments are made at each visit, at least daily, during the study.

Secondary

Measure	Time frame
Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses	Blood samples will be taken during the study.
Evaluation of the pharmacodynamic effects of AZD7325	Test batteries will be performed at specified times both before and following study drug administration.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.	A single blood sample will be obtained.

Countries

United States

Outcome results

None listed

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