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

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: AZD1386; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Macclesfield, Cheshire, United Kingdom
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD1386; 7 groups receiving a specified volume of the active component AZD1386 at different points of time.	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 Comparator: Placebo; 7 groups receiving a specified volume of placebo at different points of time	Drug: Placebo; Oral admin. of doses at 11 days through a 12 days period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Rolf Karlsten, Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden; Principal Investigator: Ray Chetty, AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: pain; Chronic pain; MAD; Multiple ascending dose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: D5090C00008; EudraCT No. 2007-005470-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No