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MAD: Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00841048
Collaborator
(none)
107
Enrollment
1
Location
2
Arms
2.9
Duration (Months)
36.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Official Title:
A Randomised, Single-blind, Placebo-controlled, Single Centre, Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
Study Start Date :
Feb 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

AZD4017 in ascending doses (start dose 75mg od)

Drug: AZD4017
ascending multiple doses(start dose 75mg od), oral suspension
Placebo Comparator: 2

Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables [The variables will be measured predose and then repeatedly during the study]

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) [Blood samples for determination of AZD4017 concentration will be taken predose and repeatedly during the study.]

  2. Laboratory screen to evaluate effect on metabolic variables [Blood samples will be taken pre-dose and repeatedly during the study]

  3. Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues [Baseline and repeatedly after treatment]

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 written and dated informed consent

  • BMI between 19 and 30 kg/m2

  • Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

  • History of any clinically significant disease

  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

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

  • Laboratory blood sample result showing elevated liver enzymes (ASAT, ALAT) and muscle enzymes (CK).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Gothenburg Sweden

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Principal Investigator: Marianne Hartford, MD PhD, AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00841048
Other Study ID Numbers:
  • D2060C00002
First Posted:
Feb 11, 2009
Last Update Posted:
Sep 30, 2009
Last Verified:
Sep 1, 2009
Keywords provided by , ,
Safety and tolerability
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 30, 2009