R3R01 single dose study in healthy adults
An Exploratory Pharmacokinetic Study to Evaluate the Exposure of R3R01 after Administration as New Polymorph in Healthy Subjects
River 3 Renal Corp
24 participants
Sep 18, 2021
Interventional
Conditions
Summary
The study will review the safety, tolerability, and PK of 3 different single, oral doses of R3R01 across 3 cohorts. It is envisaged that 24 (12 men and 12 women)participants will be recruited in the study. The following doses will be used in this study: Cohort A - R3R01 25 mg once Cohort B - R3R01 100 mg once Cohort C - R3R01 200 mg once. 8 participants will be enrolled in each cohort (4 men:4 Women). In each cohort, R3R01 will be administered on Day 1. Participants will be admitted to the clinic on the day prior to dosing and remain in the clinic until discharged on the morning of Day 2 following completion of all scheduled study procedures and assessments. Safety will be assessed through the reporting of AEs, vital signs measurements, ECGs and clinical laboratory results. The study will be 15 weeks (from screening through study completion) for each enrolled subject as follows: • Screening: Up to 3 weeks. • Dosing period: 1 day. • In-house stay: 3 days (Day -1 to Day 2 in the morning) • Follow up: day 84 (+/- 4 days)
Eligibility
Inclusion Criteria3
- to 45 years of age
- A BMI between 18 to 32 kg/m2
- Participants of childbearing potential must agree use highly effective methods of contraception
Exclusion Criteria17
- Participation in an investigational drug/device study within 3 months
- A history of clinically significant gastro-intestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic, broncho-pulmonary or neurological conditions, allergic disease or lipid metabolism disorders.
- A history of clinically significant drug hypersensitivity.
- A known history of porphyria, myopathy, or an active liver disease.
- Total bilirubin exceeding 1.5-fold upper limit of normal.
- clinically significant symptoms of an infectious illness within four weeks of dosing or a history of recurrent infections.
- Positive urine, breath or blood test for drugs of abuse and alcohol
- Positive for hepatitis B, hepatitis C, or HIV 1 and 2
- Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg and heart rate greater than 100 or less than 45 beats per minute.
- Personal or family history of congenital long QT syndrome.
- ECGs with QRS and/or T-wave judged by the investigator to be unfavorable
- Clinically significant abnormalities in laboratory test results
- Donation of blood over 450 mL within three months prior to screening.
- Smoker or non-smoker less than 6 months.
- Taking any drug or herbal medication that is an inhibitor or inducer of CYP450 within 4 weeks prior to the first dosing.
- Use of any prescription drug within 7 days of first dose of study drug
- Administration of live (attenuated) vaccines within 4 weeks before dosing
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Interventions
R3R01 - Oral capsules administered once only at doses below: Cohort A: 25 mg (1 tablet of 25 mg) Cohort B: 100 mg (1 tablet of 100 mg) Cohort C: 200 mg (2 tablets of 100 mg) Cohorts will immediately follow to the next cohort once one cohort is complete. Each cohort is distinct and participants will be enrolled into only one of the above cohorts. Tablets will given under direct supervision and mouth check ensure tablet is taken as directed.
Locations(1)
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ACTRN12621001019897