Assessment of the safety and distribution of NVB302 in healthy volunteers
- Conditions
- Clostridium difficile infectionInfections and Infestations
- Registration Number
- ISRCTN40071144
- Lead Sponsor
- ovacta Biosystems Limited (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Measured by adverse events, vital signs, ECG and routine laboratory assessments.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters: <br>1. Plasma: Cmax, Tmax, t½, AUC0-t and AUC0<br>2. Urine: Aeu (Amount of drug excreted)<br>3. Faeces: Aef (Amount of drug excreted)