Study of the Effects of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of DS-1040b

NCT02647307 | Completed Phase 1

• 2 other identifiers: DS1040-A-E1082015-003470-32
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is not hypothesis testing but is intended to explore the effects of different ethnic groups (Caucasian, Japanese, Chinese, and Korean) on the PK (pharmacokinetic), PD (pharmacodynamic), and safety of an IV infusion of DS 1040b. Subjects entering the study will receive a single 12 hour infusion of DS-1040b and be followed up to assess the effects on ethnicity on blood levels of DS-1040b as well as safety \& tolerability.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Plasma concentrations of DS-1040

  Plasma concentrations of DS-1040 and derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040.

  Day 1 to Day 6

• Cmax Concentration Maximum

  derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

  Day 1 to Day 6

• Tmax time of maximum concentration

  derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

  Day 1 to Day 6

• AUC Area under curve

  derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

  Day 1 to Day 6

• C12h concentration in plasma 12 hours after infusion

  derived PK parameters up to 6 days after a single 20 mg intravenous infusion of DS-1040

  Day 1 to Day 6

Secondary Outcomes (8)

• number and severity of adverse events

  Day 1 to Day 6

• number and severity of changes in clinical laboratory findings

  Day 1 to Day 6

• number and severity of changes in physical exam findings

  Day 1 to Day 6

• number and severity of changes in vital sign findings

  Day 1 to Day 6

• number and severity of changes in 12-lead electrocardiogram ECG findings

  Day 1 to Day 6

Study Arms (1)

DS-1040b

EXPERIMENTAL

Single 12-hour intravenous infusion of DS-1040b (20 mg).

Drug: DS-1040b

Interventions

DS-1040b DRUG

Single 12-hour intravenous infusion of DS-1040b (20 mg)

DS-1040b

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged ≥ 18 years to 60 years, inclusive.
• Caucasian, Japanese, Chinese and Korean must have both parents and all 4 grandparents of equivalent descent.
• Subjects with a body mass index (BMI) of ≥ 18 kg/m2 to 30 kg/m2, inclusive, and weighing ≥ 50 kg to 100 kg, inclusive. BMI is calculated as weight \[kg\]/(height \[m\])2.
• Subjects must be in good health as determined by medical history, physical examination and Screening investigations, and taking no regular medication.
• Willing to comply with all study restrictions, including the use of contraception, concomitant medication and dietary and lifestyle restrictions.
• Possessing sufficient intelligence to understand the nature of the study and any hazards of participating in it, and the ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire study.
• Has given written consent to participate after reading the informed consent form (ICF), and after having the opportunity to discuss the study with the Investigator or delegate.
• Have given written consent to have his data entered into The Overvolunteering Prevention System.

You may not qualify if:

• Clinically relevant abnormal history, physical findings, ECG findings or laboratory values that could interfere with the objectives of the study or the safety of the subject.
• Presence or history of acute or chronic illness, including (but not limited to) liver (Gilbert's Syndrome is permitted) or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body organ dysfunction.
• Presence or history of severe adverse reaction to any medicine.
• Presence or history of malignant disease.
• Significant illness within 4 weeks before the dose of study medication.
• Dosed in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical trials during the study and for 3 months after receipt of study medication.
• Participation in another clinical study with DS-1040b.
• Blood pressure (BP) and heart rate (HR) in semi supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; HR 40 beats/min to 100 beats/min. A subject with vital signs values outside the reference range for the population being studied may be included at the Investigator's discretion if it is unlikely to introduce additional risk factors and will not interfere with study procedures.
• Abnormal ECG waveform morphology at Screening that would preclude accurate measurement of the uncorrected QT interval (QT) duration.
• QT interval for HR corrected using Fridericia's formula (QTcF) interval duration \> 430 msec obtained as an average from the measurements on triplicate Screening ECGs.
• Use of any prescription medicine, over the counter (OTC) medications, herbal remedies (such as St John's Wort), or food known to be strong inhibitors or strong inducers of cytochrome (CYP) enzymes during the 30 days before the dose of study medication; use of any other prescription or OTC medicine (except as permitted), including dietary supplements or herbal remedies, during the 7 days before receiving study medication.
• Consumption of certain foods or beverages before the dose and throughout the study period
• Loss of more than 400 mL blood (or plasma), or donation of platelets or other blood components during the 3 months before the dose of study medication, or unwilling to abstain from doing so during the study and for 3 months after receipt of study medication.
• Abuse of drugs or alcohol in the past, or intake of more than 21 units of alcohol weekly.
• Moderate to heavy use of tobacco products or nicotine containing products (eg ≥ 5 cigarettes per day during the 3 months before the dose of study medication.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Hammersmith Medicines Research: collaborator

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 6, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 24, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

GB (1)