Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00972049

Enrollment

Registered

2009-09-04

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2010-03-04

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

Conditions

Healthy

Keywords

safety, tolerability, AZD2516, pain, Japanese

Brief summary

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.

Interventions

DRUGAZD2516

Capsule administered once orally. Specific dose depends on dose panel.

DRUGPlacebo

Capsule administered once orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2 * Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)

Exclusion criteria

* History of previous or ongoing somatic or psychiatric disease/condition * Abnormalities in ECG that may interfere with interpretation of data.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG	Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3

Secondary

Measure	Time frame
Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects	Blood sampling at defined timepoints during residential period and follow-up

Countries

Japan

Outcome results

None listed

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