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

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 Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD6765; Drug: AZD6765

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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; Drug: AZD6765; Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.
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; Drug: AZD6765; Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Phillip Leese, MD, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 10, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteers; Phase 1
• Other Study ID Numbers: D6703C00001