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Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04542252
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals

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
Drug Drug Interaction Drug: SyB V-1901 Drug: Cyclosporine 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Crossover Study to Evaluate the Drug Interaction of Coadministered Cyclosporine on the Pharmacokinetics and Safety of Intravenous Administration of SyB V-1901 in Japanese Healthy Subjects
Estimated Study Start Date : November 9, 2020
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of brincidofovir (BCV) [ Time Frame: From initiation of SyB V-1901 administration though 16 days ]
  2. Area under the plasma concentration versus time curve (AUC) of BCV [ Time Frame: From initiation of SyB V-1901 administration though 16 days ]

Secondary Outcome Measures :
  1. Cmax of cidofovir (CDV) [ Time Frame: From initiation of SyB V-1901 administration though 16 days ]
  2. AUC of CDV [ Time Frame: From initiation of SyB V-1901 administration though 16 days ]
  3. Cmax of Intercellular Cidofovir diphosphate (CDV-PP) in Peripheral Blood Mononuclear Cells (PBMCs) [ Time Frame: From initiation of SyB V-1901 administration though 18 days ]
  4. AUC of Intercellular CDV-PP in PBMCs [ Time Frame: From initiation of SyB V-1901 administration though 18 days ]
  5. Cmax of cyclosporine in blood [ Time Frame: From initiation of cyclosporine administration though 16 days ]
  6. AUC of cyclosporine in blood [ Time Frame: From initiation of cyclosporine administration though 16 days ]
  7. Number of subjects with adverse events (AE) [ Time Frame: Follow up 22 days post dose ]
  8. Number of subjects with severity of AEs [ Time Frame: Follow up 22 days post dose ]
  9. Number of subjects with abnormal findings for laboratory parameters [ Time Frame: Follow up 22 days post dose ]
  10. Number of subjects with abnormal findings for blood pressure [ Time Frame: Follow up 22 days post dose ]
  11. Number of subjects with abnormal findings for respiratory rate [ Time Frame: Follow up 22 days post dose ]
  12. Number of subjects with abnormal findings for heart rate [ Time Frame: Follow up 22 days post dose ]
  13. Number of subjects with abnormal findings for temperature [ Time Frame: Follow up 22 days post dose ]

Other Outcome Measures:
  1. Genotype of CYP4F2 [ Time Frame: Pre-Day1 ]
  2. Genotype of OATP1B1 [ Time Frame: Pre-Day1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • Creatinine Clearance ≥ 60 mL/min at screening
  • Judged to be in good general health, based on the review of medical history and the screening and Pre-Day1 examination

Main Exclusion Criteria:

  • Positive for HIV antibody, or HBs antigen, or HCV antibody at the screening or within 6 months prior to the start of screening
  • 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
  • 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
  • Have a history of drug abuse or alcohol dependence within 2 years prior to the start of screening
  • 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.
  • 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.
  • Have a history of hematological disorders or have a risk of gastrointestinal bleeding
  • 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.
  • Have increased Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) greater than ULN at screening or Pre-Day1
  • 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
  • Have symptoms of infection within 2 weeks prior to Pre-Day1
  • Have clinically significant abnormal hemoglobin at the screening or Pre-Day1, or a clinically significant iron deficiency
  • 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
  • Have received any investigational drug, or device within 30 days prior to Day1
  • History of tobacco- or nicotine-containing product use within 6 months prior to Day1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542252


Contacts
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Contact: Katsuya Ikuta +81-80-3937-4030 kikuta.ki08@symbiopharma.com

Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
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Study Director: Takeshi Yoshida SymBio Pharmaceuticals
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Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04542252    
Other Study ID Numbers: BCV-HV01
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors