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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: AZD1386; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690079

D5090C00008

EudraCT No. 2007-005470-31

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

AZD1386

Experimental group

Description:

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

Treatment:

Drug: AZD1386

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo