A Study of Ascending Multiple Doses of Oral Surotomycin in Healthy Participants (MK-4261-009)

NCT02835118 | Completed Phase 1

• 1 other identifier: 4261-009
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.

Conditions

Clostridium Difficile Associated Diarrhea (CDAD)

Outcome Measures

Primary Outcomes (2)

• Number of participants with an Adverse Event (AE)

  Up to Day 21

• Number of participants who discontinued study treatment due to an AE

  Up to Day 14

Study Arms (4)

Surotomycin 0.5 g

EXPERIMENTAL

Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Drug: Surotomycin

Surotomycin 1 g

EXPERIMENTAL

Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Drug: Surotomycin

Surotomycin 2 g

EXPERIMENTAL

Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Drug: Surotomycin

Placebo

PLACEBO COMPARATOR

Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days

Drug: Placebo

Interventions

Surotomycin DRUG

Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days

Also known as: CB-183,315

Surotomycin 0.5 g; Surotomycin 1 g; Surotomycin 2 g

Placebo DRUG

Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has no evidence of prior chronic gastrointestinal inflammatory disease such as inflammatory bowel disease
• Electrocardiogram (ECG) shows no clinically significant abnormalities
• Is in good health

You may not qualify if:

• Pregnant or lactating females
• Has prior exposure to surotomycin
• 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 that has 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 donated blood or blood products 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 known hypersensitivity to daptomycin

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

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: 28347318 DERIVED

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: July 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 22, 2016

Record last verified: 2016-07