Clinical trial NCT00841048: Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Keywords: Safety and tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
timeFrame: The variables will be measured predose and then repeatedly during the study
Secondary outcomes:
measure: 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)
timeFrame: Blood samples for determination of AZD4017 concentration will be taken predose and repeatedly during the study.
measure: Laboratory screen to evaluate effect on metabolic variables
timeFrame: Blood samples will be taken pre-dose and repeatedly during the study
measure: Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues
timeFrame: Baseline and repeatedly after treatment
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden
name: Marianne Hartford, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: