A Phase I, Randomised, Double-Blind, Placebo-Controlled,AscendingSingle- and Repeat-Dose Study of the Safety,Tolerability andPharmacokinetics of Orally Administered PRN473.
- Conditions
- Healthy VolunteersOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12613000951752
- Lead Sponsor
- Clinical Network Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 114
1.adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening
2. Body mass index (BMI) >18.0 and < 30.5 (kg/m2) (inclusive)
3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent
4. If male, agrees to be sexually abstinent or to use a condom or other adequate method of contraception
5. Female participants must be surgically sterile or post-menopausal
6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
1. Pregnant or lactating females, and male partners of women who are pregnant or lactating
2. Females of child-bearing potential
3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
4. Any active acute or chronic disease judged to be clinically significant by the Investigator
5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to begining the study
6. History or presence of alcoholism or drug abuse within the 2 years prior to begining the study
7. History of any significant (as determined by the Invest
igator) drug-related allergic reactions
8. Use of any over-the-counter (OTC) medication
9. Participation in another clinical trial of a drug or device within 60 days.
10. Surgery within the past three months
11. Hypertension
12. Hypersensitivity to lactose
13. Regular alcohol consumption >14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
14. History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
15. Any acute illness within 30 days prior to Day 1 of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method