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A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT04680429
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

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 will also be evaluated for RP7214. The study comprises three parts; Part 1: Single ascending dose, Part 2: Multiple ascending dose and Part 3: Food effect.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RP7214 Drug: Placebo Phase 1

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 ratio. Within each cohort, two sentinel subjects (RP7214 and Placebo) will be dosed first for assessment of safety and tolerability. The safety data of at least 48 hrs will be reviewed to confirm safety of sentinel subjects after which the remaining four subjects will be dosed. Food effect study is a randomized, 2-treatment, 2-period, 2-sequence, crossover study in 12 HVs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study and Food Effect Study of Oral RP7214, a DHODH Inhibitor, in Healthy Volunteers
Actual Study Start Date : December 29, 2020
Actual Primary Completion Date : July 17, 2021
Actual Study Completion Date : July 19, 2021

Arm Intervention/treatment
Experimental: RP7214, Single and multiple doses

In Part 1 up to 3 cohorts with single ascending doses of RP7214 at 100 mg QD, 200 mg QD and 400 mg QD.

In Part 2 up to 2 cohorts with multiple ascending doses of RP7214 at 200 mg BID, 400 mg BID.

Drug: RP7214
Participants will receive single and multiple ascending doses of RP7214

Placebo Comparator: Placebo, Single and multiple doses
In Part 1 up to 3 cohorts and in Part 2 up to 2 cohorts with matching placebo to RP7214 tablet
Drug: Placebo
Participants will receive single and multiple ascending doses of matching placebo




Primary Outcome Measures :
  1. Assessments of Adverse Events (AEs) [ Time Frame: Day1 - day15 ]

Secondary Outcome Measures :
  1. RP7214 Cmax [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Maximum Observed Plasma Concentration

  2. RP7214 Tmax [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Time for maximum plasma concentration

  3. RP7214 t½ [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Terminal half-life

  4. RP7214 AUC0-inf [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Area under the plasma concentration time curve from zero extrapolated to infinite time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects willing and able to provide informed consent for the trial
  2. Male and non-childbearing female subjects aged 18 to 55 years
  3. 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
  4. Non-tobacco user/non-smokers or ex-smokers defined as someone who has stopped smoking cigarettes for at least 6 months.
  5. Negative screen for drugs of abuse and alcohol at screening and on admission.
  6. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
  7. 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.
  8. Female subjects should be of non-childbearing potential.
  9. Willing and able to understand the nature of this study, comply with the study procedures as required by the study protocol.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Pregnant or lactating females.
  6. Clinically significant abnormalities in physical examination and/or in laboratory tests (including hematology and chemistry panels, urinalysis) as assessed by the Investigator.
  7. 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.
  8. 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.
  9. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680429


Locations
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United States, Nevada
Rhizen Investigational Site
Las Vegas, Nevada, United States, 89121
United States, North Dakota
Rhizen Investigational Site
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT04680429    
Other Study ID Numbers: RP7214-2002
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhizen Pharmaceuticals SA:
DHODH