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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386 (MAD)

Primary Purpose

Chronic Pain

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

AZD1386

Placebo

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring MAD, Multiple ascending dose, Chronic pain, pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria:

History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD1386

Placebo

Arm Description

7 groups receiving a specified volume of the active component AZD1386 at different points of time.

7 groups receiving a specified volume of placebo at different points of time

Outcomes

Primary Outcome Measures

Safety AEs and vital signs

ECG-recordings

Secondary Outcome Measures

Full Information

NCT ID

NCT00690079

First Posted

June 2, 2008

Last Updated

December 8, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00690079

Brief Title

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

Acronym

MAD

Official Title

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

MAD, Multiple ascending dose, Chronic pain, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AZD1386

Arm Type

Experimental

Arm Description

7 groups receiving a specified volume of the active component AZD1386 at different points of time.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

7 groups receiving a specified volume of placebo at different points of time

Intervention Type

Drug

Intervention Name(s)

AZD1386

Intervention Description

Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral admin. of doses at 11 days through a 12 days period.

Primary Outcome Measure Information:

Title

Safety AEs and vital signs

Time Frame

During the whole study

Title

ECG-recordings

Time Frame

ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13.

Secondary Outcome Measure Information:

Title

Time Frame

Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit. Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG Exclusion Criteria: History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study. History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity. Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolf Karlsten

Organizational Affiliation

Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ray Chetty

Organizational Affiliation

AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Macclesfield

State/Province

Cheshire

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

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