Condition category
Infections and Infestations
Date applied
03/08/2011
Date assigned
16/08/2011
Last edited
27/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Salvatore Febbraro

ORCID ID

Contact details

Simbec Research Limited
Merthyr Tydfil
CF48 4DR
United Kingdom

Additional identifiers

EudraCT number

2011-002703-14

ClinicalTrials.gov number

Protocol/serial number

NVB302/001

Study information

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

Acronym

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

South East Wales Research Ethics Committee, 25/07/ 2011, ref: 11/WA/0205

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

Trial setting

Other

Trial type

Screening

Patient information sheet

Not provided at time of registration

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

Phase

Phase I

Drug names

NVB302

Primary outcome measures

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 trial start date

26/10/2011

Overall trial end date

16/03/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Maximum of 72 subjects

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

Trial participating centre

Simbec Research Limited
Merthyr Tydfil
CF48 4DR
United Kingdom

Sponsor information

Organisation

Novacta Biosystems Limited (UK)

Sponsor details

c/o Mrs Anne Hancock
BioPark Hertfordshire
Broadwater Park
Welwyn Garden City
AL7 3AX
United Kingdom

Sponsor type

Industry

Website

http://www.novactabio.com/

Funders

Funder type

Industry

Funder name

Novacta Biosystems Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/04/2016: No publications found, verifying study status with principal investigator