AZD6765 Oral single ascending dose/multiple ascending dose (SAD/MAD)
Study identifier:D6703C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment on Hold
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
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD6765
Sex
All
Actual Enrollment
66
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: -
Estimated Study Completion Date: 01 Mar 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Other
Verification:
Verified 01 Jan 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Phillip Leese
Quintiles, Inc
