Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

Chronic Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690079
• Other study ID #: D5090C00008
• Secondary ID: EudraCT No. 2007
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2008
• Last updated: December 8, 2010
• Start date: February 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• AZD1386
Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L
• Placebo
Oral admin. of doses at 11 days through a 12 days period.

Locations

Country	Name	City	State
United Kingdom	Research Site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety AEs and vital signs		During the whole study	Yes
Primary	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.	Yes
Secondary	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.	Yes