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

AstraZeneca

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Conditions

Healthy

Interventions

AZD6765DRUG

Single oral dose and single IV infusion of AZD6765

AZD6765DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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

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.

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.

Data from ClinicalTrials.gov

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