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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963365

Enrollment

Registered

2009-08-21

Start date

2008-11-30

Completion date

2010-03-31

Last updated

2014-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, Healthy volunteers

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.

Interventions

DRUGAZD6765

Single oral dose and single IV infusion of AZD6765

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026