A Study Conducted Over 3 Periods to Look at the Drug in the Body

A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01225939

Enrollment

Registered

2010-10-21

Start date

2010-11-30

Completion date

2010-12-31

Last updated

2011-03-02

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, Healthy

Brief summary

A study conducted over 3 periods to look at the drug in the body.

Interventions

DRUGAZD8329

tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5 * suitable veins for cannulation or repeated venepuncture * Subjects should have a body mass index (BMI) between 18 and 30 kg/m2

Exclusion criteria

* Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator * Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome * Suspicion of known Gilbert's disease * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Design outcomes

Primary

Measure	Time frame
Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329.	Information will be collected during 48h after each dose.

Secondary

Measure	Time frame
Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation.	Information will be collected during 48h after dose.
Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG))	Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits

Countries

United Kingdom

Outcome results

None listed

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