Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690079

Acronym

MAD

Enrollment

Registered

2008-06-04

Start date

2008-02-29

Completion date

2008-10-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

MAD, Multiple ascending dose, Chronic pain, pain

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.

Interventions

DRUGAZD1386

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026