Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551
Status and phase
Terminated
Phase 1
Conditions
Healthy
Treatments
Drug: Placebo
Drug: AZD2551
Details and patient eligibility
About
The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body
Enrollment
90 estimated patients
Sex
Male
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
- Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg
Exclusion criteria
- Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
- History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
- Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
90 participants in 2 patient groups, including a placebo group
1
Experimental group
Treatment:
Drug: AZD2551
2
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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