Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

NCT00690079

Chronic Pain

COMPLETED PHASE1

Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704

NCT00692042

Pain

COMPLETED PHASE1

Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects

NCT00953888

Healthy

COMPLETED PHASE1

A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

NCT00741689

Healthy Volunteers

COMPLETED PHASE1

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

NCT00796965

Healthy Volunteer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Capsaicin Evoked Pain Heat Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

36 subjects receiving a specified volume of the active component AZD1386 in a single dose.

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

Oral solution fixed dose (95 mg given orally on two occasions)

2

36 subjects receiving a specified volume of placebo in a single dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution fixed dose (95 mg given orally on two occasions)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD1386

Oral solution fixed dose (95 mg given orally on two occasions)

Intervention Type DRUG

Placebo

Oral solution fixed dose (95 mg given orally on two occasions)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
* Non-fertile females

Exclusion Criteria

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes