ADME study for [14C]-BC-3781 in healthy males (QCL117656)
Research type
Research Study
Full title
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
IRAS ID
214686
Contact name
Lori Lykens
Contact email
Sponsor organisation
Nabriva Therapeutics AG
Eudract number
2016-003541-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
The Sponsor is developing the study drug Lefamulin, BC-3781, for the potential treatment of a number of different infections such as respiratory tract infections and bacterial skin and skin structure infections for example cellulitis, cutaneous abscesses and infected wounds, ulcers, or burns. The study drug may also be appropriate for development in the treatment of other infections including sexually transmitted diseases.
Lefamulin is a strong, semi-synthetic antibacterial drug belonging to a new class of antibacterial drugs known as the pleuromutilins. An antibacterial is a drug that interferes with the growth and reproduction of bacteria. Semi-synthetic antibacterials are those that have been partially modified from a naturally occurring drug in order to improve the effectiveness of the drug, reduce it's side effects, help against bacteria developing resistance to the drug or expand the types of bacteria the drug can affect.
The study will use radiolabelled doses of BC-3781 to identify how the study drug is taken up, absorbed and removed by the body. The safety and tolerability of the drug will also be assessed.
The study will consist of 2 cohorts, each containing 5 healthy male volunteers. Volunteers assigned to Cohort A will receive a single radiolabelled dose of study drug given as a long, slow injection (60 minutes).
Volunteers assigned to Cohort B will receive a single dose of 600 mg study drug given as 3 capsules to swallow.REC name
Wales REC 1
REC reference
16/WA/0294
Date of REC Opinion
1 Nov 2016
REC opinion
Further Information Favourable Opinion