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WithdrawnNCT00963365Updated Oct 13, 2014

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

A Phase 1 interventional study of AZD6765 and AZD6765 in Healthy, sponsored by AstraZeneca. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-13.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Phase 1
  • Healthy volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    AZD6765 oral solution

    Active

    Drug: AZD6765

  • Experimental
    AZD6765 IV infusion

    Active

    Drug: AZD6765

  • Placebo comparator
    Placebo to AZD6765 oral solution

    Placebo

    Drug: AZD6765

  • Placebo comparator
    Placebo to AZD6765 IV infusion

    Placebo

    Drug: AZD6765

Interventions

  • DrugAZD6765

    Single oral dose and single IV infusion of AZD6765

  • DrugAZD6765

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

06

What researchers measure

Primary outcomes

  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).

    Time frame: Safety assessments are made prior to and after drug administration.

Secondary outcomes

  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

    Time frame: 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

    Time frame: Blood samples will be obtained on Days 1-4 and 7-11.

07

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00963365
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 21, 2009
Start date
Nov 2008
Primary completion
Feb 2009 (estimated)
Completion
Mar 2010 (estimated)
Last update
Oct 13, 2014

Study contacts

Phillip Leese, MD
principal investigator · Quintiles, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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