A First Time in Man Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1979 in Healthy Males
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/5/2014 |
| Start Date: | March 2014 |
| End Date: | August 2014 |
| Contact: | Quintiles Drug Research Unit Call Center, 0800 634 1132 |
| Email: | ClinicalTrialTransparency@astrazeneca.com |
A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers
This is a first time in human study to assess the safety and tolerability of AZD1979
following oral administration of single ascending doses in healthy male volunteers.
Pharmacokinetics (what the body does to the drug) parameters will also be assessed as
secondary objectives.
following oral administration of single ascending doses in healthy male volunteers.
Pharmacokinetics (what the body does to the drug) parameters will also be assessed as
secondary objectives.
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures
- Healthy male volunteer aged 18 to 50 years
- Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more
than 100 kg, inclusive
Exclusion Criteria:
- History of any clinically important disease or disorder which, in the opinion of the
Investigator, may either put the volunteer at risk because of participation in the
study, or influence the results or the volunteer's ability to participate in the
study
- History or presence of gastrointestinal, hepatic, or renal disease or any other
condition known to interfere with absorption, distribution, metabolism, or excretion
of drugs
- Any clinically important illness, medical/surgical procedure, or trauma within 4
weeks of the first administration of IP
- Any clinically important abnormalities in clinical chemistry, endocrine hormones,
hematology, or urinalysis results as judged by the Investigator
We found this trial at
1
site
Click here to add this to my saved trials
