A Phase 1, Single-Center, Open-label Study to Evaluate the Safety and Pharmacokinetics of Two Tablet Formulations of PRN1008 in healthy adult volunteers.

Principia Biopharma Australia Pty Ltd0 sites14 target enrollmentNovember 11, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Principia Biopharma Australia Pty Ltd
Enrollment: 14
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Principia Biopharma Australia Pty Ltd

Eligibility Criteria

Inclusion Criteria

•Healthy adult male or non\-pregnant, non\-lactating females, 18 to 65 years of age (inclusive) at the time of screening
•\- Body mass index (BMI) greater than or equal to 18 (kg/m2\) (inclusive), and less than or equal to 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
•\- A female subject of childbearing potential with a negative pregnancy test agrees to abstinence or use of condoms plus one other acceptable form of contraception; i.e. intrauterine device, hormonal contraception, or a female diaphragm, until 4 weeks after dosing with study drug – OR – has only same\-sex partners, when this is her preferred and usual lifestyle
•\- Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug
•\- Negative urine drug/alcohol testing at screening and check\-in (Day \-1\). Screening urine drug/alcohol testing may be repeated once if deemed appropriate by the site Investigator
•\- Willing to abstain from consuming grapefruit\- or Seville orange\-containing products from 14 days prior to first dose of study medication through follow\-up

Exclusion Criteria

•\- Use of any prescription or over\-the\-counter (OTC) medication, including herbal products and supplements, within the 14 days or 5 half\-lives prior to Day 1 (whichever is longer). Use of less than or equal to 2g paracetamol per day is allowed prior to and during the study.
•\- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HCV)
•\- Use of more than two tobacco/nicotine\-containing products per month within 6 months prior to the first study drug administration
•\- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
•\- Regular alcohol consumption of greater than 14 units per week (1 unit \= 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
•\- History of any significant (as determined by the Investigator) drug\-related allergic reactions such as, anaphylaxis, Stevens\-Johnson syndrome, urticarial 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