Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

A Phase I, Randomized, Double-blind (with-in Panel), Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Healthy Elderly Volunteers After Oral Multiple Ascending Doses of AZD0328

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00687141

Enrollment

112

Registered

2008-05-30

Start date

2007-11-30

Completion date

2008-06-30

Last updated

2010-12-10

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

Conditions

Alzheimer's Disease

Keywords

Safety, tolerability, AZD0328

Brief summary

The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.

Interventions

DRUGAZD0328

Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.

DRUGPlacebo

Administered orally as a solution once per day on day 1, and then day 3 through to day 14.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed informed consent * Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator

Exclusion criteria

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder * History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity * Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG	Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.
Safety and tolerability of AZD0328 by assessment of adverse events	Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study.

Secondary

Measure	Time frame
Determine the single and multiple dose pharmacokinetics (PK) of AZD0328	PK sampling taken at defined timepoints during residential period.
Evaluate the cognitive dose response relationship for AZD0328	Psychometric test battery performed at defined timepoints during residential period.

Countries

Sweden

Outcome results

None listed

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