## Protocol Section
### Identification Module
**NCT ID:** NCT00690079

**Acronym:** MAD

**Brief Title:** Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

**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.

#### Organization Study ID Info
**ID:** D5090C00008
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** EudraCT No. 2007-005470-31
### Status Module
#### Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-12-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-12-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2009-01

#### Study First Post Date
**Date:** 2008-06-04
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-02
**Study First Submit QC Date:** 2008-06-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Old Name Title:** Rolf Karlsten, MD, PhD Medical Science Director

**Old Organization:** AstraZeneca R&D Södertälje SE-151 85 Södertälje, Sweden

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronic Pain

**Keywords:**

- MAD

- Multiple ascending dose

- Chronic pain

- pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 69

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: AZD1386

**Label:** AZD1386

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AZD1386

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

**Name:** AZD1386

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

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

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Safety AEs and vital signs

**Time Frame:** During the whole study

**Measure:** ECG-recordings

**Time Frame:** 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 Outcomes

**Measure:** PK

**Time Frame:** 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.

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Macclesfield

**Country:** United Kingdom

**Facility:** Research Site

**State:** Cheshire

#### Overall Officials

**Official 1:**

**Affiliation:** Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

**Name:** Rolf Karlsten

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG

**Name:** Ray Chetty

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-24
