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A Study Conducted Over 3 Periods to Look at the Drug in the Body

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01225939
Collaborator
(none)
18
Enrollment
1
Location
3
Arms
30
Duration (Days)
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study conducted over 3 periods to look at the drug in the body.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 After Single Doses of the Oral Solid Formulation and the Oral Solution
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Single Oral dose AZD8329 tablet (fasting)

Drug: AZD8329
tablet
Experimental: 2

Single Oral dose AZD8329 solution (fasting)

Drug: AZD8329
Solution
Experimental: 3

Single Oral dose AZD8329 tablet (Fed)

Drug: AZD8329
tablet

Outcome Measures

Primary Outcome Measures

  1. Compare the pharmacokinetics (Cmax and AUC) of the oral solution and the oral solid formulation of AZD8329. [Information will be collected during 48h after each dose.]

Secondary Outcome Measures

  1. Explore the effect of food on the pharmacokinetics (Tmax, T1/2 and CL/F) of AZD8329 oral solid formulation. [Information will be collected during 48h after dose.]

  2. Investigate the safety and tolerability of AZD8329 administered as two different oral formulations.(Safety variables: Adverse events, Vital Signs, Clinical chemistry, Electrocardiogram (p ECG)) [Adverse event will be collected from first dose to last visit . Clinical chemistry, Vital Signs and pECG's will be collected at all 5 visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5

  • suitable veins for cannulation or repeated venepuncture

  • Subjects should have a body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria:

  • Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator

  • Prolonged QTcF >450 msec or shortened QTcF <350 msec or family history of long QT syndrome

  • Suspicion of known Gilbert's disease

  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site London Bridge United Kingdom

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: J Ritter, BM BCh, MRCP, FRCP, Quintiles Drug Research Unit at Guy's Hospital
  • Study Chair: Dr. Mirjana Kujacic, AstraZeneca Mölndal
  • Study Director: Jan Eriksson, MD PhD, AstraZeneca Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01225939
Other Study ID Numbers:
  • D2350C00007
First Posted:
Oct 21, 2010
Last Update Posted:
Mar 2, 2011
Last Verified:
Mar 1, 2011
Keywords provided by , ,
Type 2 diabetes mellitus
Healthy
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 2, 2011