Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: AZD1386; Drug: Placebo

• Registration Number: NCT00690079
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1386	AZD1386	7 groups receiving a specified volume of the active component AZD1386 at different points of time.
Placebo	Placebo	7 groups receiving a specified volume of placebo at different points of time

Primary Outcome Measures

Name	Time	Method
Safety AEs and vital signs	During the whole study
ECG-recordings	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 Measures

Name	Time	Method
PK	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Macclesfield, Cheshire, United Kingdom