ACTRN12621001019897
Completed
Phase 1
An Exploratory Pharmacokinetic Study to Evaluate the Exposure of R3R01 afterAdministration as New Polymorph in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alport syndrome
- Sponsor
- River 3 Renal Corp
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 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 Criteria
- •\-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.
Outcomes
Primary Outcomes
Not specified
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