HealthyPhase 1NCT02969252
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers
A Phase 1 study testing Rifamycin SV-MMX® 600 in people with Healthy, run by Cosmo Technologies Ltd.
Trial summary
The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rifamycin SV-MMX® 600
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Aug 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men and women, 18-55 year old inclusive
- Body Mass Index: 18.5-30 kgm2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
- Fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year.
- For all female subjects, pregnancy test result had to be negative at screening and Day -1
Who cannot join
- ECG 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
- Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study
Show all 13Show fewer
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- Blood donation: blood donations for 3 months before this study
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol (more than 1 drink a day for females and more than 2 drinks a day for males, defined according to the USDA Dietary Guidelines 2010), caffeine (more than 5 cups coffee/tea/day) or tobacco abuse (10 cigarettes a day)
- Abuse drug test: positive result at the drug test at screening or Day-1
- Alcohol test: positive alcohol breath test at Day -1
- Diet: abnormal diets (less than1600 or more than 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
- Pregnancy (females only): positive or missing pregnancy test at screening or Day -1, pregnant or lactating women
About this study
Official title: Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers. Single and Multiple Dose, Open Label, Pharmacokinetics and Safety Study
The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.
- Conditions
- Healthy
- Being tested
- Rifamycin SV-MMX® 600
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycin SV-MMX® 600Drug
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | Single and multiple dose, open label, pharmacokinetics and safety study Receives: Drug: Rifamycin SV-MMX® 600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax,0-24 h
Measured: Day 1
Cmax
Cmax,0-6
Measured: Day 1
tmax
tmax,0-24
Measured: Day 1
tmax
tmax,0-6
Measured: Day 1
AUC
AUC 0-24
Measured: Day 1
AUC
AUC 0-6
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionAug 2015
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 HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969252
- Sponsor's protocol ID
- CB-01-11/27
- Status last verified
- Jan 2018
- First submitted
- 14 Nov 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
Publications
Di Stefano AFD, Radicioni MM, Vaccani A, Mazzetti A, Longo LM, Moro L. Pharmacokinetics and Safety of Rifamycin SV after Single and Multiple Doses of MMX(R) Modified Release Tablets in Healthy Male and Female Volunteers. Antibiotics (Basel). 2021 Feb 6;10(2):167. doi: 10.3390/antibiotics10020167.
PubMed 33562091
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers. Single and Multiple Dose, Open Label, Pharmacokinetics and Safety Study
- ClinicalTrials.gov ID
- NCT02969252
- Acronym / sponsor ID
- CB-01-11/27
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- First posted
- 21 Nov 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.
The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | Drug: Rifamycin SV-MMX® 600Single and multiple dose, open label, pharmacokinetics and safety study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent: signed written informed consent before inclusion in the study
- Sex and Age: men and women, 18-55 year old inclusive
- Body Mass Index: 18.5-30 kgm2 inclusive
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (13 listed)
- ECG 12-leads (supine position): clinically significant abnormalities
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study
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 |
|---|---|---|
| Rifamycin SV-MMX® 600 | Drug | Open label |
Primary outcome
Cmax
Time frame: Day 1
Cmax,0-24 h
Cmax
Time frame: Day 1
Cmax,0-6
tmax
Time frame: Day 1
tmax,0-24
tmax
Time frame: Day 1
tmax,0-6
AUC
Time frame: Day 1
AUC 0-24
AUC
Time frame: Day 1
AUC 0-6
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 26 Jan 2018.
- Derived from this study: PubMed 33562091Di Stefano AFD, Radicioni MM, Vaccani A, Mazzetti A, Longo LM, Moro L. Pharmacokinetics and Safety of Rifamycin SV after Single and Multiple Doses of MMX(R) Modified Release Tablets in Healthy Male and Female Volunteers. Antibiotics (Basel). 2021 Feb 6;10(2):167. doi: 10.3390/antibiotics10020167.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rifamycin SV-MMX® 600 in people with Healthy, run by Cosmo Technologies Ltd.
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 7 inclusion and 13 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 26 Jan 2018. 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. 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?
Cmax (time frame: Day 1). The study lists 6 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 NCT02969252, 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 26 Jan 2018.