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

NCT04542252 | Completed Phase 1

• 1 other identifier: BCV-HV01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

Other Outcomes (2)

• Genotype of CYP4F2

  Pre-Day1

• Genotype of OATP1B1

  Pre-Day1

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Cyclosporine

Group 2

EXPERIMENTAL

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; Drug: Cyclosporine

Interventions

SyB V-1901 DRUG

SyB V-1901 10 mg via IV infusion for 2 hours

Group 1; Group 2

Cyclosporine DRUG

200 mg Capsule

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (1)

Research Site

Hachioji-shi, Tokyo, Japan

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Takeshi Yoshida

  SymBio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 9, 2020
• Study Start: November 9, 2020
• Primary Completion: December 22, 2020
• Study Completion: January 29, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

JP (1)