An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-BC-3781 Administered Via the Intravenous or Oral Routes to Healthy Male Subjects

Nabriva Therapeutics AG1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2017年1月8日最近更新: 2018年4月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Nabriva Therapeutics AG
入组人数: 10
试验地点: 1
主要终点: Amount of radioactivity eliminated in urine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via the intravenous or oral routes.

详细描述

This is a single-centre, open-label, non-randomised, single dose study to assess the pharmacokinetics, mass balance recovery, and metabolite profiling and identification following administration of iv or oral 14C-BC-3781 to healthy male subjects It is planned to enrol 2 cohorts of 5 subjects or 10 subjects in total. The active substance being investigated in this study is radiolabeled lefamulin ([14C] BC 3781), present in the investigational medicinal products (IMPs) as the acetate salt ([14C]-BC-3781.Ac).

Subjects assigned to Cohort A will receive a single IV administration of 14C-BC-3781 containing 150 mg BC-3781 and not more than (NMT) 4.3 MBq (117 µCi) 14C, administered as an infusion over 60 min after a light breakfast.

Subjects assigned to Cohort B will receive a single oral administration of 14C-BC-3781 containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

盲法说明

open label

入排标准

年龄范围: 30 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy males
•Aged 30 to 65 years
•Body mass index of 18.0 to 35.0 kg/m2, inclusive
•Must have regular bowel movements
•Must provide written informed consent
•Must agree to use an adequate method of contraception

排除标准

•Subjects who have received any IMP in a clinical research study within the previous 3 months
•History of any drug or alcohol abuse in the past 2 years
•Regular alcohol consumption in males >21 units per week and females >14 units per week
•Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
•Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
•Subjects who have been dosed in an ADME study in the last 12 months
•Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
•Positive drugs of abuse test result at screening and admission
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
•Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
•Significant history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorders as judged by the investigator
•A familial history or presence of Long QT syndrome
•Subjects with QT interval corrected according to Fridericia's formula (QTcF) >480 ms
•A serum potassium level of less than 3.5 mmol/L at screening
•Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
•Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
•Donation or loss of greater than 400 mL of blood within the previous 3 months
•Have taken medications known to be strong P-gp inhibitors, or strong CYP3A4 inducers or inhibitors, within 28 days before IMP administration
•Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol or herbal remedies) in the 14 days before IMP administration

研究组 & 干预措施

Cohort A

Experimental

Cohort A will receive a single IV administration of 14C-BC-3781 containing 150 mg BC-3781 and NMT 4.3 MBq (117 µCi) 14C, administered as an infusion over 60 min after a light breakfast

干预措施: BC-3781 (Drug)

Cohort B

Experimental

Cohort B will receive a single oral administration of 14C-BC-3781 containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state

干预措施: BC-3781 (Drug)