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

Healthy Clinical Trial

Official title:

Pt. A: Ph I, Sngl-Blind, Randomized, Pcbo-Controlled 3-Way Crossover Study Followed by an Open-label Food Effect Study to Assess the PK of IV and Oral AZD6765 in Healthy Male and Female Subjects Pt.B: Ph I, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and PK of AZD6765 When Administered in Multiple Ascending Doses to Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00963365
• Other study ID #: D6703C00001
• Status: Withdrawn
• Phase: Phase 1
• First received: August 20, 2009
• Last updated: October 10, 2014
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD6765
Single oral dose and single IV infusion of AZD6765
• AZD6765
Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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.	No