Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses (MAD)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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).
Trial design
107 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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