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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: AZD6765

• Registration Number: NCT00963365
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-02
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Study Completion: 2010-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AZD6765 oral solution	AZD6765	Active
AZD6765 IV infusion	AZD6765	Active
Placebo to AZD6765 oral solution	AZD6765	Placebo
Placebo to AZD6765 IV infusion	AZD6765	Placebo

Primary Outcome Measures

Name	Time	Method
The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG).	Safety assessments are made prior to and after drug administration.

Secondary Outcome Measures

Name	Time	Method
Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765	Blood samples will be obtained on Days 1-5.
Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765	Blood samples will be obtained on Days 1-4 and 7-11.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States