## Protocol Section
### Identification Module
**NCT ID:** NCT00686179

**Acronym:** TQT

**Brief Title:** Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days

**Official Title:** A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.

#### Organization Study ID Info
**ID:** D3690C00004
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** EUdract NO 2007-004859-11
### Status Module
#### Completion Date
**Date:** 2008-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-09-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-09-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-08

**Type:** ACTUAL

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2008-09

#### Study First Post Date
**Date:** 2008-05-29
**Type:** ESTIMATED
**Study First Submit Date:** 2008-05-27
**Study First Submit QC Date:** 2008-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Old Name Title:** Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AZD3480

**Old Organization:** AstraZeneca R&D, Södertälje, Sweden

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- TQT

- ECG

- QT

- QTc

- AZD3480

- ECG(QTc effects)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 75

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Escalating doses of AZD3480 during 6 days

**Intervention Names:**

- Drug: AZD3480

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Repeated doses of AZD3480 during 6 days

**Intervention Names:**

- Drug: AZD3480

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo during 6 days

**Intervention Names:**

- Drug: PLACEBO

**Label:** 3

**Type:** PLACEBO_COMPARATOR

#### Arm Group 4

**Description:** Placebo during 5 days, active day 6

**Intervention Names:**

- Drug: Moxifloxacin

**Label:** 4

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** Capsule, oral, single dose, 6 days

**Name:** AZD3480

**Other Names:**

- TC-1734-226

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 4

**Description:** Capsule(encapsulated), oral, single dose

**Name:** Moxifloxacin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 3

**Description:** Capsule, oral, single dose

**Name:** PLACEBO

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3

**Time Frame:** 11 dECG measurements x 4 (4-way crossover)

#### Secondary Outcomes

**Measure:** QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals

**Time Frame:** 11 dECG measurements x 4 (4-way crossover)

**Measure:** Plasma concentration (AUC, Cmax, tmax etc)

**Time Frame:** 11 PK-measurements x 4 (4-way crossover)

**Measure:** Registration of AEs, blood pressure, ECG, clinical laboratory tests

**Time Frame:** From enrolment to follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
* Physically and mentally healthy male volunteers

Exclusion Criteria:

* History of clinically significant diseases or illness.
* Participation in another study the last 3 months
* Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

**Name:** Hans-Göran Hårdemark

**Role:** STUDY_DIRECTOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

### Intervention Browse Module - Browse Leaves

- ID: M1722

- Name: Moxifloxacin

- Relevance: HIGH

- As Found: Range

- ID: M13561

- Name: Phenylephrine

- Relevance: LOW

- As Found: Unknown

- ID: M13031

- Name: Oxymetazoline

- Relevance: LOW

- As Found: Unknown

- ID: M266292

- Name: Norgestimate, ethinyl estradiol drug combination

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077266

- Term: Moxifloxacin

### Misc Info Module

- Version Holder: 2024-05-24
