AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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AZD6765 oral solution

Active

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

Single oral dose and single IV infusion of AZD6765

AZD6765

Intervention Type DRUG

Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.

AZD6765 IV infusion

Active

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

Single oral dose and single IV infusion of AZD6765

Placebo to AZD6765 oral solution

Placebo

Group Type PLACEBO_COMPARATOR

AZD6765

Intervention Type DRUG

Single oral dose and single IV infusion of AZD6765

AZD6765

Intervention Type DRUG

Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.

Placebo to AZD6765 IV infusion

Placebo

Group Type PLACEBO_COMPARATOR

AZD6765

Intervention Type DRUG

Single oral dose and single IV infusion of AZD6765

Interventions

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AZD6765

Single oral dose and single IV infusion of AZD6765

Intervention Type DRUG

AZD6765

Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Females must be of non-childbearing potential.

Exclusion Criteria

* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was \< 24 hours) of the first administration of study drug
* Plasma or blood product donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes