Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00729443

Acronym

SAD

Enrollment

Registered

2008-08-07

Start date

2008-07-31

Completion date

2008-11-30

Last updated

2008-11-13

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

Conditions

Healthy Volunteers

Keywords

Single dose, Phase 1, Safety of AZD3241, tolerability of AZD3241

Brief summary

The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers

Interventions

DRUGAZD3241

single oral dose

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of informed consent * Body Mass Index (BMI) 19 to 30 kg/m2 inclusive * Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion criteria

* Clinically significant illness within the 2 weeks prior to the administration of the investigational product * Heart rate (resting, recumbent) \<50 bmp or \>85 bmp * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator

Design outcomes

Primary

Measure	Time frame
General tolerability and safety variables	2 weeks

Secondary

Measure	Time frame
pk	approximately 48 hour

Countries

Sweden

Outcome results

None listed

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