Status:
COMPLETED
A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects
Lead Sponsor:
Rhizen Pharmaceuticals SA
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind study to evaluate the safety, tolerability and PK of single and multiple ascending oral doses of RP7214. The relative bioavailability in fed and fasting conditions w...
Detailed Description
There are three escalating cohorts in SAD part and two escalating cohorts in MAD part. In each cohort, six eligible healthy volunteers will be randomized to receive either RP7214 or placebo in 2:1 rat...
Eligibility Criteria
Inclusion
- Subjects willing and able to provide informed consent for the trial
- Male and non-childbearing female subjects aged 18 to 55 years
- Healthy subjects as determined by pre-study medical history, vitals, physical examination and 12-lead ECG, and clinical laboratory tests within the normal reference ranges or clinically acceptable to investigator
- Non-tobacco user/non-smokers or ex-smokers defined as someone who has stopped smoking cigarettes for at least 6 months.
- Negative screen for drugs of abuse and alcohol at screening and on admission.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
- A male subject who is able to procreate should agree to use one of the accepted contraceptives and agree to refrain from donating sperm for at least 3 months after dosing; and should not father a child during this period.
- Female subjects should be of non-childbearing potential.
- Willing and able to understand the nature of this study, comply with the study procedures as required by the study protocol.
Exclusion
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) at the time of screening.
- Positive screen for hepatitis-B surface antigen (HBsAg), antibodies to the hepatitis C (HCV) or antibodies to the human immunodeficiency virus (HIV) 1 and 2.
- Subjects who received or are on Covid-19 directed prophylaxis (e.g. chloroquine or hydroxychloroquine) in last two weeks or 5x half-lives of the drug, whichever is shorter, prior to dosing.
- Subjects participating in another clinical study or use of any investigational product in last 30 days or 5x half-lives of the drug, whichever is shorter, prior to dosing.
- Pregnant or lactating females.
- Clinically significant abnormalities in physical examination and/or in laboratory tests (including hematology and chemistry panels, urinalysis) as assessed by the Investigator.
- Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulations/procedures.
- Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study.
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04680429
Start Date
December 29 2020
End Date
July 19 2021
Last Update
August 18 2021
Active Locations (2)
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1
Rhizen Investigational Site
Las Vegas, Nevada, United States, 89121
2
Rhizen Investigational Site
Fargo, North Dakota, United States, 58104