ACTRN12615000614594
Completed
Phase 1
A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Clinical Network Services (CNS) Pty Ltd
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Healthy adult male or non\-pregnant non\-lactating females, 40 to 75 years of age (inclusive) at the time of screening.
- •\*Body mass index (BMI) equal to or greater than 18 and equal to or less than 35 (kg/m2\) (inclusive) and a minimum body weight of 45 kg.
- •\*Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •\*Negative urine drug/alcohol testing at screening and check\-in (Day \-1\).
Exclusion Criteria
- •\*Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- •\*History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •\*History of any significant (as determined by the Investigator) drug\-related allergic reactions such as, anaphylaxis, Stevens\-Johnson syndrome, urticaria or multiple drug allergies.
- •\*Blood donation or significant blood loss within 30 days prior to screening.
- •\*Plasma donation within 14 days prior to the first study drug administration.
- •\*Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half\-lives, whichever is longer.
- •\*Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
- •\*Personal or family history of prolonged QT syndrome or family history of sudden death.
- •\*QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, unless deemed clinically insignificant by the Investigator.
- •\*Seated resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg.
Outcomes
Primary Outcomes
Not specified
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