Clostridium Difficile Associated Diarrhea (CDAD)Phase 1NCT02835105
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
A Phase 1 study testing Surotomycin in people with Clostridium Difficile Associated Diarrhea (CDAD), run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Associated Diarrhea (CDAD)
- What is being tested?
- Surotomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
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.
- Being tested
- Surotomycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurotomycinDrug
Also called CB-183,315
A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules
PlaceboDrug
A single oral dose of placebo for surotomycin in hard gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Surotomycin 0.5 g | Experimental | A single oral dose of 0.5 g surotomycin in hard gelatin capsules Receives: Drug: Surotomycin |
| Surotomycin 1 g | Experimental | A single oral dose of 1 g surotomycin in hard gelatin capsules Receives: Drug: Surotomycin |
| Surotomycin 2 g | Experimental | A single oral dose of 2 g surotomycin in hard gelatin capsules Receives: Drug: Surotomycin |
| Surotomycin 4 g | Experimental | A single oral dose of 4 g surotomycin in hard gelatin capsules Receives: Drug: Surotomycin |
| Placebo | Placebo comparator | A single oral dose of placebo for surotomycin in hard gelatin capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an Adverse Event (AE)
Measured: Up to Day 9
Number of participants who discontinued study due to an AE
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile Associated Diarrhea (CDAD)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835105
- Sponsor's protocol ID
- 4261-008
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28347318
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Single-Dose, Safety and Pharmacokinetic Study of Ascending Doses of CB-183,315 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02835105
- Acronym / sponsor ID
- 4261-008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Surotomycin 0.5 g | Experimental | Drug: SurotomycinA single oral dose of 0.5 g surotomycin in hard gelatin capsules |
| Surotomycin 1 g | Experimental | Drug: SurotomycinA single oral dose of 1 g surotomycin in hard gelatin capsules |
| Surotomycin 2 g | Experimental | Drug: SurotomycinA single oral dose of 2 g surotomycin in hard gelatin capsules |
| Surotomycin 4 g | Experimental | Drug: SurotomycinA single oral dose of 4 g surotomycin in hard gelatin capsules |
| Placebo | Placebo comparator | Drug: PlaceboA single oral dose of placebo for surotomycin in hard gelatin capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurotomycinAlso: CB-183,315A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules | Drug | Surotomycin 0.5 g, Surotomycin 1 g, Surotomycin 2 g, Surotomycin 4 g |
| PlaceboA single oral dose of placebo for surotomycin in hard gelatin capsules | Drug | Placebo |
Primary outcome
Number of participants with an Adverse Event (AE)
Time frame: Up to Day 9
Number of participants who discontinued study due to an AE
Time frame: Up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Derived from this study: PubMed 28347318Chandorkar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surotomycin in people with Clostridium Difficile Associated Diarrhea (CDAD), run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with an Adverse Event (AE) (time frame: Up to Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016.