Clostridium difficile infection Infections and Infestations Clostridium difficile infection
Conditions
Interventions
Part A (Single dose): Up to five cohorts of eight subjects will be randomized to receive one of five single oral doses of NVB302 with a starting dose of 100mg or a single oral dose of Placebo. The dos
Sponsors
Novacta Biosystems Limited (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects, between 18 and 64 years of age (inclusive) 2. Female subjects must be postmenopausal or surgically sterilised 3. Female subject of non-child bearing potential with negative pregnancy test at screening 4. Male subjects must be willing to use an effective method of contraception from day 1 until 3 months afterwards 5. Subject has a healthy gastro-intestinal (GI) tract with no clinically significant history of GI disease (including any disorder likely to influence drug absorption) or bowel surgery
Exclusion criteria
Exclusion criteria: 1. Any relevant abnormality in medical history or on examination, including history of dementia, or other psychiatric, neurological, immunological, respiratory or cardiovascular disorder 2. Presence of Clostridium difficile toxin in faecal sample 3. Participation in a clinical study of an unlicensed drug in the previous 16 weeks, or a marketed drug study within the previous 12 weeks 4. Known allergies, including allergy to drugs with a similar chemical structure or class to NVB302 (Type B lantibiotics) or its constituents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Measured by adverse events, vital signs, ECG and routine laboratory assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: 1. Plasma: Cmax, Tmax, t½, AUC0-t and AUC0 2. Urine: Aeu (Amount of drug excreted) 3. Faeces: Aef (Amount of drug excreted) | — |
Countries
United Kingdom
Outcome results
None listed