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
| Registry | NCT03131141 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, basic science |
| Enrollment | 10 (Actual) |
| Sponsor | Nabriva Therapeutics AG (Industry); collaborators: Quotient Clinical |
| Conditions | Healthy |
| Interventions | BC-3781 (Drug) |
| Dates | start 2017-01-08, primary completion 2017-10-09, completion 2018-03-30, first posted 2017-04-27, last updated 2018-04-03 |
| Locations | 1 site in United Kingdom |
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All trials for Healthy All trials of BC-3781
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort A | Experimental | Drug: BC-3781 | 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 |
| Cohort B | Experimental | Drug: BC-3781 | 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 |
Sex: Male, ages: 30 Years to 65 Years, accepts healthy volunteers
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 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Quotient Clinical | Nottingham | United Kingdom |