Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00754715

Enrollment

Registered

2008-09-18

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2008-12-15

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

Conditions

Healthy

Keywords

Multiple dosing study,, safety

Brief summary

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

Interventions

DRUGAZD2516

Solution administered once orally

DRUGPlacebo

Solution administered only once

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

* Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old. * Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables	From first to last visit

Secondary

Measure	Time frame
Safety and tolerability of AZD2516 by assessment of non-serious adverse events	Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516	PK sampling taken at defined timepoints during residential period

Countries

Sweden

Outcome results

None listed

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