## Protocol Section
### Identification Module
**NCT ID:** NCT00771979

**Brief Title:** Relative Bioavailability of Phase II and Phase III Formulations of AZD0530

**Official Title:** A Phase I, Randomised, Open-Label, Cross-Over, Single Centre Study in Healthy Volunteers to Determine the Relative Bioavailability of the Phase III Tablet Formulation to the Phase II Tablet Formulation of AZD0530

#### Organization Study ID Info
**ID:** D8180C00033
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-06-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-06-17

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2008-11

**Status Verified Date:** 2009-06

#### Study First Post Date
**Date:** 2008-10-15
**Type:** ESTIMATED
**Study First Submit Date:** 2008-10-14
**Study First Submit QC Date:** 2008-10-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Old Name Title:** Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology

**Old Organization:** AstraZeneca Pharmaceuticals

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of the study is to compare how different formulations of AZD0530 are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Healthy Volunteers

- Relative Bioavailability

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 18

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: AZD0530

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** of both the Phase II and Phase III AZD0530 125mg tablet variants (A and B) in a random order.

**Name:** AZD0530

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

**Description:** Part II: Single doses of AZD0530 125mg oral solution and 2 out of 4 125mg tablet variants (C, D, E and F) in a random order.

**Name:** AZD0530

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** To compare the pharmacokinetic parameters for AZD0530 when administered as Phase III formulation in relation to Phase II formulation.

**Time Frame:** Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.

#### Secondary Outcomes

**Measure:** To monitor the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.

**Time Frame:** From time of consent to last visit.

**Measure:** An exploratory objective is to characterise the Pharmacokinetic profile of an oral solution of AZD0530 and 4 additional tablet variants of the Phase III formulation of AZD0530

**Time Frame:** Pre-dose sample, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168 hours post dose samples.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female subjects must be of Non- child-bearing potential
* Body mass index between 19 and 30 kg/m2 and weigh between 50-100 kg

Exclusion Criteria:

* Presence of any clinically significant illness
* Abnormal vital signs
* History of any conditions that may put the subject at risk by participating in the study
* Participation in another clinical study.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alderley Park

**Country:** United Kingdom

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** AstraZeneca, Clinical Pharmacology Unit, Alderley Park

**Name:** Raj Chetty, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** AstraZeneca,Parklands, Alderley Park

**Name:** Mary Stuart, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M239759

- Name: Saracatinib

- Relevance: HIGH

- As Found: Fibrin Sealant

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000515233

- Term: Saracatinib

### Misc Info Module

- Version Holder: 2024-05-24
