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 site in 1 country10 target enrollmentJanuary 8, 2017

ConditionsHealthy

InterventionsBC-3781

DrugsBC-3781

Overview

Phase: Phase 1
Intervention: BC-3781
Conditions: Healthy
Sponsor: Nabriva Therapeutics AG
Enrollment: 10
Locations: 1
Primary Endpoint: Amount of radioactivity eliminated in urine
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

January 8, 2017

End Date

March 30, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Nabriva Therapeutics AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Cohort A

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

Intervention: BC-3781

Cohort B

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

Intervention: BC-3781