NCT02835105

Brief Summary

This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.

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

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

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

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

2 months

First QC Date

July 13, 2016

Last Update Submit

July 21, 2016

Conditions

Clostridium Difficile Associated Diarrhea (CDAD)

Outcome Measures

Primary Outcomes (2)

  • Number of participants with an Adverse Event (AE)

    Up to Day 9

  • Number of participants who discontinued study due to an AE

    Up to Day 9

Study Arms (5)

Surotomycin 0.5 g

EXPERIMENTAL

A single oral dose of 0.5 g surotomycin in hard gelatin capsules

Drug: Surotomycin

Surotomycin 1 g

EXPERIMENTAL

A single oral dose of 1 g surotomycin in hard gelatin capsules

Drug: Surotomycin

Surotomycin 2 g

EXPERIMENTAL

A single oral dose of 2 g surotomycin in hard gelatin capsules

Drug: Surotomycin

Surotomycin 4 g

EXPERIMENTAL

A single oral dose of 4 g surotomycin in hard gelatin capsules

Drug: Surotomycin

Placebo

PLACEBO COMPARATOR

A single oral dose of placebo for surotomycin in hard gelatin capsules

Drug: Placebo

Interventions

SurotomycinDRUG

A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules

Also known as: CB-183,315
Surotomycin 0.5 gSurotomycin 1 gSurotomycin 2 gSurotomycin 4 g
PlaceboDRUG

A single oral dose of placebo for surotomycin in hard gelatin capsules

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease or gastroesophageal reflux disease documented on endoscopy
  • Electrocardiogram (ECG) shows no clinically significant abnormalities
  • Is able to swallow capsules
  • is in good health

You may not qualify if:

  • Pregnant or lactating females
  • Has had Clostridium (C.) difficile disease within 1 year prior to entry into the study
  • Has received an investigational drug or participated in any experimental procedure within1 month prior to study entry and at least 6 half lives from last intake of study drug
  • Participants 18 to 49 years of age had taken any regular, prescribed, or over-the-counter medication
  • Has any significant concurrent therapies
  • Has a positive drug screen
  • Has a positive human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C screen
  • Has given more than 450 mL of blood (one unit) in the 60 days preceding screening
  • Is an active intravenous drug user or abuses alcohol
  • Has had a malignancy within the last 5 years
  • Has inadequate protection against pregnancy during the conduct of the study and until 1 month after last dose of study drug
  • Has received any antibiotics within 30 days prior to first dose of study drug
  • Has been hospitalized within the past 30 days prior to Study Day 1
  • Has known hypersensitivity to daptomycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chandorkar G, Zhan Q, Donovan J, Rege S, Patino H. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers. BMC Pharmacol Toxicol. 2017 Mar 28;18(1):24. doi: 10.1186/s40360-017-0123-z.

    PMID: 28347318DERIVED

MeSH Terms

Interventions

CB-183,315

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 22, 2016

Record last verified: 2016-07