Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects
Study Details
Study Description
Brief Summary
To evaluate the effect of coadministered cyclosporine on the pharmacokinetics of brincidofovir following simultaneous administration of SyB V-1901 with cyclosporine, or coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion in healthy adult subjects
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
This study is an open-label, randomized and crossover study designed to evaluate the effect of cyclosporine on the pharmacokinetics of SyB V-1901. Healthy adult subjects will receive an IV dose of SyB V-1901 alone, simultaneous administration of SyB V-1901 with cyclosporine, and coadministration of cyclosporine at 2 hours after completion of SyB V-1901 infusion. Eligible subjects will be randomized to one of two groups, to receive the treatment sequence of assigned group.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 SyB V-1901 alone, Simultaneous administration of SyB V-1901 and cyclosporine, Coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion |
Drug: SyB V-1901
SyB V-1901 10 mg via IV infusion for 2 hours
Drug: Cyclosporine
200 mg Capsule
|
Experimental: Group 2 Simultaneous administration of SyB V-1901 and cyclosporine, SyB V-1901 alone, Coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion |
Drug: SyB V-1901
SyB V-1901 10 mg via IV infusion for 2 hours
Drug: Cyclosporine
200 mg Capsule
|
Outcome Measures
Primary Outcome Measures
- Maximum Plasma Concentration (Cmax) of brincidofovir (BCV) [From initiation of SyB V-1901 administration though 16 days]
- Area under the plasma concentration versus time curve (AUC) of BCV [From initiation of SyB V-1901 administration though 16 days]
Secondary Outcome Measures
- Cmax of cidofovir (CDV) [From initiation of SyB V-1901 administration though 16 days]
- AUC of CDV [From initiation of SyB V-1901 administration though 16 days]
- Cmax of Intercellular Cidofovir diphosphate (CDV-PP) in Peripheral Blood Mononuclear Cells (PBMCs) [From initiation of SyB V-1901 administration though 18 days]
- AUC of Intercellular CDV-PP in PBMCs [From initiation of SyB V-1901 administration though 18 days]
- Cmax of cyclosporine in blood [From initiation of cyclosporine administration though 16 days]
- AUC of cyclosporine in blood [From initiation of cyclosporine administration though 16 days]
- Number of subjects with adverse events (AE) [Follow up 22 days post dose]
- Number of subjects with severity of AEs [Follow up 22 days post dose]
- Number of subjects with abnormal findings for laboratory parameters [Follow up 22 days post dose]
- Number of subjects with abnormal findings for blood pressure [Follow up 22 days post dose]
- Number of subjects with abnormal findings for respiratory rate [Follow up 22 days post dose]
- Number of subjects with abnormal findings for heart rate [Follow up 22 days post dose]
- Number of subjects with abnormal findings for temperature [Follow up 22 days post dose]
Other Outcome Measures
- Genotype of CYP4F2 [Pre-Day1]
- Genotype of OATP1B1 [Pre-Day1]
Eligibility Criteria
Criteria
Main Inclusion Criteria:
-
Healthy adult male aged between 20 to 55 years at informed consent
-
BMI from 18 to 32 kg/m2 with a body weight of ≥ 50 kg
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Creatinine Clearance ≥ 60 mL/min at screening
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Judged to be in good general health, based on the review of medical history and the screening and Pre-Day1 examination
Main Exclusion Criteria:
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Positive for HIV antibody, or HBs antigen, or HCV antibody at the screening or within 6 months prior to the start of screening
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Have a history of infection of SARS-CoV-2, or subjects who have close contact with infected patients of SARS-CoV-2 within 2 weeks prior to screening or visit to epidemic area of SARS-CoV-2 infection in outside of Japan or have close contact with person who visit to epidemic area of SARS-CoV-2 infection within 2 weeks prior to screening
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Positive for SARS-CoV-2 polymerase chain reaction (PCR) in lower respiratory tract specimens, nasopharyngeal swabs or saliva and so on at screening or have a fever ≥ 37.5 °C and respiratory symptoms
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Have a history of drug abuse or alcohol dependence within 2 years prior to the start of screening
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Have a history of gastrointestinal disorders or cholecystectomy etc., which could interfere with the absorption of cyclosporine or could interfere with normal gastrointestinal anatomy or motility, but except for uncomplicated appendectomy.
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Have a history or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, and clinically significant cardiac disorder.
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Have a history of hematological disorders or have a risk of gastrointestinal bleeding
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Have a history of chronic liver disease or hepatic impairment, including but not limited to alcoholic liver disease, chronic viral hepatitis, autoimmune hepatitis, steatosis or hemochromatosis.
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Have increased Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) greater than ULN at screening or Pre-Day1
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History of Gilbert's syndrome or increased total bilirubin greater than 1.5x the upper limit of the normal range at screening or Pre-Day1
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Have symptoms of infection within 2 weeks prior to Pre-Day1
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Have clinically significant abnormal hemoglobin at the screening or Pre-Day1, or a clinically significant iron deficiency
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Have a history of blood donation or had clinically significant blood loss within 30 days prior to Day 1, or platelet/plasma donation within 7 days prior to Day 1
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Have received any investigational drug, or device within 30 days prior to Day1
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History of tobacco- or nicotine-containing product use within 6 months prior to Day1
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Research Site | Hachioji-shi | Tokyo | Japan |
Sponsors and Collaborators
- SymBio Pharmaceuticals
Investigators
- Study Director: Takeshi Yoshida, SymBio Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCV-HV01