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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 17, 2020
First Posted Date  ICMJE December 23, 2020
Last Update Posted Date August 18, 2021
Actual Study Start Date  ICMJE December 29, 2020
Actual Primary Completion Date July 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2020)
Assessments of Adverse Events (AEs) [ Time Frame: Day1 - day15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2020)
  • RP7214 Cmax [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Maximum Observed Plasma Concentration
  • RP7214 Tmax [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Time for maximum plasma concentration
  • RP7214 t½ [ Time Frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose ]
    Terminal half-life
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: RP7214
    Participants will receive single and multiple ascending doses of RP7214
  • Drug: Placebo
    Participants will receive single and multiple ascending doses of matching placebo
Study Arms  ICMJE
  • 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.

    Intervention: Drug: 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2021)
42
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2020)
18
Actual Study Completion Date  ICMJE July 19, 2021
Actual Primary Completion Date July 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04680429
Other Study ID Numbers  ICMJE RP7214-2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rhizen Pharmaceuticals SA
Study Sponsor  ICMJE Rhizen Pharmaceuticals SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rhizen Pharmaceuticals SA
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP