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

NCT ID: NCT04542252

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-01-29

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

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.

Conditions

Drug Drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SyB V-1901

Intervention Type: DRUG

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

Cyclosporine

Intervention Type: DRUG

200 mg Capsule

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

Group Type: EXPERIMENTAL

SyB V-1901

Intervention Type: DRUG

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

Cyclosporine

Intervention Type: DRUG

200 mg Capsule

Interventions

SyB V-1901

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

Intervention Type: DRUG

Cyclosporine

200 mg Capsule

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takeshi Yoshida

Role: STUDY_DIRECTOR

SymBio Pharmaceuticals

Locations

Research Site

Hachioji-shi, Tokyo, Japan

Countries

Japan

Other Identifiers

BCV-HV01

Identifier Type: -

Identifier Source: org_study_id