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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00963365
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 4
• Duration (Months): 15.9
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD6765; Drug: AZD6765	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: Nov 1, 2008
• Anticipated Primary Completion Date: Feb 1, 2009
• Anticipated Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD6765 oral solution Active	Drug: AZD6765; Single oral dose and single IV infusion of AZD6765; Drug: AZD6765; Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.
Experimental: AZD6765 IV infusion Active	Drug: AZD6765; Single oral dose and single IV infusion of AZD6765
Placebo Comparator: Placebo to AZD6765 oral solution Placebo	Drug: AZD6765; Single oral dose and single IV infusion of AZD6765; Drug: AZD6765; Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.
Placebo Comparator: Placebo to AZD6765 IV infusion Placebo	Drug: AZD6765; Single oral dose and single IV infusion of AZD6765

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.]

2. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Phillip Leese, MD, Quintiles, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00963365
• Other Study ID Numbers: D6703C00001
• First Posted: Aug 21, 2009
• Last Update Posted: Oct 13, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by AstraZeneca: Phase 1; Healthy volunteers

Study Results

No Results Posted as of Oct 13, 2014