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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00963365
First received: August 20, 2009
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Healthy
Drug: AZD6765
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). [ Time Frame: Safety assessments are made prior to and after drug administration. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Blood samples will be obtained on Days 1-5. ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Blood samples will be obtained on Days 1-4 and 7-11. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963365

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Phillip Leese, MD Quintiles
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00963365     History of Changes
Other Study ID Numbers: D6703C00001
Study First Received: August 20, 2009
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
Healthy volunteers

ClinicalTrials.gov processed this record on November 20, 2014