Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00796965

Enrollment

Registered

2008-11-24

Start date

2008-12-31

Completion date

2009-03-31

Last updated

2009-08-19

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

Conditions

Healthy Volunteer

Keywords

Phase 1

Brief summary

Single Ascending Dose Study

Interventions

DRUGAZD7268

Solution/Capsule, Oral, once daily

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of Informed Consent * Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion criteria

* Inability to understand or cooperate with given information * Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test * Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.	Safety assessments are made at each visit, at least daily, during the study.

Secondary

Measure	Time frame
To characterize the pharmacokinetics of AZD7268 in plasma and urine.	Blood and urine samples will be taken during the study.
To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.	Safety assessments and blood and urine samples will be taken throughout the study.

Countries

United States

Outcome results

None listed

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