Assessment of the safety and distribution of NVB302 in healthy volunteers
| ISRCTN | ISRCTN40071144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40071144 |
| EudraCT/CTIS number | 2011-002703-14 |
| Secondary identifying numbers | NVB302/001 |
- Submission date
- 03/08/2011
- Registration date
- 16/08/2011
- Last edited
- 27/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Salvatore Febbraro
Scientific
Scientific
Simbec Research Limited
Merthyr Tydfil
CF48 4DR
United Kingdom
Study information
| Study design | Single and multiple dose, double-blind, randomised, placebo-controlled, single centre dose escalating Phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not provided at time of registration |
| Scientific title | A phase I, double-blind, randomised, placebo-controlled, dose escalating study to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of NVB302 administered orally to healthy volunteers |
| Study hypothesis | To evaluate the safety and tolerability of single and multiple oral ascending doses of NVB302 in healthy male and female subjects Please note that as of 23/10/2012, the following changes were made to this record: 1. The anticipated start date was updated from 24/08/2011 to 26/10/2011 2. The anticipated end date was updated from 21/12/2011 to 16/03/2012 |
| Ethics approval(s) | South East Wales Research Ethics Committee, 25/07/ 2011, ref: 11/WA/0205 |
| Condition | Clostridium difficile infection |
| Intervention | 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 dose of NVB302 will be administered in an ascending dose fashion from Cohort 1 to 5. Within each cohort, 6 subjects will receive NVB302 and 2 subjects will receive placebo. Subjects will be followed up for 10 days Part B (Multiple dose): Up to four cohorts of eight subjects will be randomized to receive either 10 days of once daily oral doses of NVB302 (6 subjects) or 10 days of once daily oral doses of placebo (2 subjects). The dose range to be studied will be selected following review of the results from completed cohorts of Part A. Subjects will be followed up for a further 14 days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | NVB302 |
| Primary outcome measure | Safety: Measured by adverse events, vital signs, ECG and routine laboratory assessments. |
| Secondary outcome measures | 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) |
| Overall study start date | 26/10/2011 |
| Overall study end date | 16/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | Maximum of 72 subjects |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 26/10/2011 |
| Recruitment end date | 16/03/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Simbec Research Limited
Merthyr Tydfil
CF48 4DR
United Kingdom
CF48 4DR
United Kingdom
Sponsor information
Novacta Biosystems Limited (UK)
Industry
Industry
c/o Mrs Anne Hancock
BioPark Hertfordshire
Broadwater Park
Welwyn Garden City
AL7 3AX
United Kingdom
| Website | http://www.novactabio.com/ |
|---|---|
"ROR" |
https://ror.org/03hyrhe39 |
Funders
Funder type
Industry
Novacta Biosystems Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/04/2016: No publications found, verifying study status with principal investigator
