A Single Oral Dose Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects

• ClinicalTrials.gov Identifier: NCT04680429
• Recruitment Status: Recruiting
• First Posted: December 23, 2020
• Last Update Posted: December 28, 2020
• Sponsor: Rhizen Pharmaceuticals SA
• Information provided by (Responsible Party): Rhizen Pharmaceuticals SA

Study Description

Brief Summary:

This Phase I first in man study in healthy volunteers is intended to evaluate safety and pharmacokinetics of singe ascending doses of RP7214 a DHODH inhibitor. This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK of RP7214 in HVs.

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

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single Escalating Doses of Oral RP7214, a DHODH Inhibitor in Healthy Volunteers
• Estimated Study Start Date: December 2020
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: June 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Participants receiving RP7214	Drug: RP7214; Participants will receive single ascending doses of RP7214 at 100 mg QD, 200 mg QD and 400 mg QD
Placebo Comparator: Placebo; Participants receiving placebo	Drug: Placebo; Participants will receive placebo

Outcome Measures

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

Eligibility Criteria

• 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. Abnormal liver function (ALT, AST or bilirubin >1.5 X upper limit of normal).
3. 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.
4. 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.
5. Subjects participating in another clinical study or use of any investigational product in last 12 weeks or 5x half-lives of the drug, whichever is shorter, prior to dosing.
6. Pregnant or lactating females.
7. Clinically significant abnormalities in physical examination and/or in laboratory tests (including hematology and chemistry panels, urinalysis) as assessed by the Investigator.
8. 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.
9. 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.
10. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.

Contacts and Locations

Contacts

Contact: Prajak Barde, MD; +41 32 580 0175; pjb@rhizen.com

Locations

United States, Nevada

Rhizen Investigational Site; Recruiting

Las Vegas, Nevada, United States, 89121

Contact: Prajak Barde, MD pjb@rhizen.com

Sponsors and Collaborators

Rhizen Pharmaceuticals SA

More Information

• Responsible Party: Rhizen Pharmaceuticals SA
• ClinicalTrials.gov Identifier: NCT04680429
• Other Study ID Numbers: RP7214-2002
• First Posted: December 23, 2020
• Last Update Posted: December 28, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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