NCT02518607

Brief Summary

This study is to assess the safety and tolerability aspects of oral MGB-BP-3, a treatment for Clostridium difficile infections.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

July 29, 2015

Last Update Submit

March 16, 2016

Conditions

Healthy

Keywords

Safety and TolerabilityMale Volunteers

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of single and repeated oral doses of MGB-BP-3 in healthy men

    Safety Assessment - Composite Metrics: vital signs, ECG, telemetry (Part A only), physical examination, laboratory safety tests, faecal occult blood, intestinal permeability (absorptive capacity test using differential sugar absorption with the urine sugars measured using LC-MS, Part B only), faecal flora (Part B only) and Tolerability (AE's \& SAE's)

    4 months

Secondary Outcomes (1)

  • To assess the pharmacokinetics (PK) of single and repeated oral doses of MGB-BP-3 in healthy men

    4 months

Study Arms (18)

Group 1, Session 1, Active

EXPERIMENTAL

Lowest dose of SAD: MGB-BP-3, 250 mg liquid filled enterically coated capsule, single dose

Drug: MGB-BP-3

Group 1, Session 2, Active

EXPERIMENTAL

Dose Escalation SAD: MGB-BP-3, 2X250 mg liquid filled enterically coated capsule, single dose

Drug: MGB-BP-3

Group 1, Session 3, Active

EXPERIMENTAL

Dose Escalation SAD MGB-BP-3, 3X250 mg liquid filled enterically coated capsules, single dose

Drug: MGB-BP-3

Group 2, Session 1, Active

EXPERIMENTAL

Dose Escalation SAD MGB-BP-3, 4X250 mg liquid filled enterically coated capsules, single dose

Drug: MGB-BP-3

Group 2, Session 2, Active

EXPERIMENTAL

Dose Escalation SAD MGB-BP-3, 5X250 mg liquid filled enterically coated capsules, single dose

Drug: MGB-BP-3

Group 2, Session 3, Active

EXPERIMENTAL

Dose Escalation SAD MGB-BP-3, 6X250 mg liquid filled enterically coated capsules, single dose

Drug: MGB-BP-3

Group 3, Active

EXPERIMENTAL

Lowest dose of MAD MGB-BP-3, 2X250 mg liquid filled enterically coated capsules (AM/PM), multiple dose for 9 days and 1 single dose on Day 10

Drug: MGB-BP-3

Group 4, Active

EXPERIMENTAL

Dose Escalation MAD MGB-BP-3, 4X250 mg liquid filled enterically coated capsules (2XAM/2XPM), multiple dose for 9 days and 1 single dose on Day 10

Drug: MGB-BP-3

Group 5, Active

EXPERIMENTAL

Dose Escalation MAD MGB-BP-3, 8X250 mg liquid filled enterically coated capsules (3XAM/3XPM), multiple dose for 9 days and 1 single dose on Day 10

Drug: MGB-BP-3

Group 1, Session 1, Placebo

PLACEBO COMPARATOR

Lowest dose of SAD: Placebo, 1 liquid filled enterically coated capsule, single dose

Other: Placebo

Group 1, Session 2, Placebo

PLACEBO COMPARATOR

Placebo, 2 liquid filled enterically coated capsules, single dose

Other: Placebo

Group 1, Session 3, Placebo

PLACEBO COMPARATOR

Placebo, 3 liquid filled enterically coated capsules, single dose

Other: Placebo

Group 2, Session 1, Placebo

PLACEBO COMPARATOR

Placebo, 4 liquid filled enterically coated capsules, single dose

Other: Placebo

Group 2, Session 2, Placebo

PLACEBO COMPARATOR

Placebo, 5 liquid filled enterically coated capsules, single dose

Other: Placebo

Group 2, Session 3, Placebo

PLACEBO COMPARATOR

Placebo, 6 liquid filled enterically coated capsules, single dose

Other: Placebo

Group 3, Placebo

PLACEBO COMPARATOR

Placebo 2 liquid filled enterically coated capsules (AM/PM), multiple dose for 9 days and 1 single dose on Day 10

Other: Placebo

Group 4, Placebo

PLACEBO COMPARATOR

Placebo 4 liquid filled enterically coated capsules (2XAM/2XPM), multiple dose for 9 days and 1 single dose on Day 10

Other: Placebo

Group 5, Placebo

PLACEBO COMPARATOR

Placebo 8 liquid filled enterically coated capsules (3XAM/3XPM), multiple dose for 9 days and 1 single dose on Day 10

Other: Placebo

Interventions

MGB-BP-3DRUG

Treatment of CDI

Also known as: MGB-BP-3-101
Group 1, Session 1, ActiveGroup 1, Session 2, ActiveGroup 1, Session 3, ActiveGroup 2, Session 1, ActiveGroup 2, Session 2, ActiveGroup 2, Session 3, ActiveGroup 3, ActiveGroup 4, ActiveGroup 5, Active
PlaceboOTHER

Placebo

Group 1, Session 1, PlaceboGroup 1, Session 2, PlaceboGroup 1, Session 3, PlaceboGroup 2, Session 1, PlaceboGroup 2, Session 2, PlaceboGroup 2, Session 3, PlaceboGroup 3, PlaceboGroup 4, PlaceboGroup 5, Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Body mass index (BMI) of 18.0-30.9 kg/m2
  • Normal blood pressure
  • healthy on the basis of a clinical history \& physical examination
  • Normal ECG
  • Normal vital signs
  • Normal laboratory tests of blood and urine
  • Willing to use reliable contraception
  • Able to give fully informed written consent

You may not qualify if:

  • Positive tests for hepatitis B \& C
  • Positive tests for HIV
  • Severe adverse reaction to any drug
  • Drug or alcohol abuse
  • Smoke more than 5 cigarettes (or use of equivalent tobacco or nicotine products) daily
  • Received over-the-counter medication within previous 7 days (with the exception of paracetamol)
  • Prescribed medication during previous 28 days
  • Participation in other clinical trials of unlicensed medicines
  • Loss of more than 400 mL blood, within the previous 3 months
  • Vital signs outside the acceptable range
  • Clinically relevant abnormal findings at the screening assessment
  • Acute or chronic illness
  • Clinically relevant abnormal medical history or concurrent medical condition
  • Possibility that volunteer will not cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

MGB-BP-3

Study Officials

  • Malcolm Boyce, Various

    HMR London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 10, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03