HealthyPhase 1CYC102NCT02130414
PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
A Phase 1 study testing Sandimmun® IV and CyCol® capsules in people with Healthy, run by Sigmoid Pharma.
Trial summary
The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sandimmun® IV and CyCol® capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Feb 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, between the ages of 18 and 55 years, inclusive.
- Mass Index (BMI) of 18.5 to 30.0 kg/m2, inclusive; and a total body weight >50 kg (110 lbs).
- Subjects capable of providing written consent.
- Subjects willing to use acceptable method of contraception starting from the first dose and continuing for at least 3 months after the last dose of study drug.
- Subjects who are willing and able to comply with scheduled visits, dosing plan, laboratory tests, and other study procedures.
- Subjects must have a regular bowel movement
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of significant drug abuse
- History of regular alcohol consumption
- Treatment with an investigational drug within 90 days prior to first dose of study medication.
- If considered clinically significant by the Investigator, screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
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- 12-lead ECG demonstrating QTcF interval >450 msec or a QRS interval >120 msec at Screening.
- Use of medications :
- prescription medications (oral and topical) within 14 days prior to first dosing.
- over-the-counter products including herbal and food supplements within 7 days prior to first dose of study medication
- injection or implant of any drug within 3 months prior to first dose of study medication
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication.
- Plasma donation within 7 days prior to dosing.
- History of sensitivity to cyclosporine or other related drugs.
- Subjects with evidence of ongoing (active or carrier status) hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
- History of latent or active tuberculosis or exposure to endemic areas within 8 weeks prior to Quantiferon test performed at screening.
- Positive Quantiferon test result
- Subjects who have received or are planning to receive any live virus vaccination within 28 days prior to the first dose of study medication, or planning to receive a vaccination during the course of the study.
- Any evidence of active infection or febrile illness within 7 days of the first dose of study medication
- Presence of fever (body temperature >37.6oC) within 2 weeks prior to first dose of study medication.
- Subjects who are unwilling to refrain from consumption of grapefruit or products containing grapefruit juice or grapefruit-related citrus fruits (eg, starfruit, pomelos) from 7 days prior to the first dose of study medication until completion of all study procedures.
- Unwilling or unable to comply with the guidelines described in this protocol, or a reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
About this study
Official title: A Multiple Dose, Multi-stage Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Colon Tissue Distribution of Cyclosporine Capsules (CyCol®) Compared to Intravenous Cyclosporine in Healthy Male Volunteers
The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.
Read the detailed description
This is an open label, multiple-dose, multi-stage pharmacokinetic (PK) study. A maximum of 40 healthy adult male volunteers aged between 18 and 55 years will be enrolled at a single clinical research unit.
For each CyCol® group dosing will last 7 days, whilst the Sandimmun® IV group will have a single dose over 24 hours.
Single dose pharmacokinetics of different doses of CyCol® will be compared to IV Sandimmun®. In addition colonic tissue concentrations will be compared after multiple doses of CyCol® to a single IV dose of Sandimmun®. Concentrations of unchanged cyclosporine and it's metabolites in the faeces will also be explored.
Stage 1 of the study will investigate the 75mg dose (OD and BID) of CyCol® and IV Sandimmun®. Then dependent on results Stages 2 and 3 will investigate either lower (37.5mg) or higher (150mg) dose levels. The dosing regimens chosen for Stages 2 and 3 will be based upon safety and tolerability, systemic exposure and colonic mucosa tissue concentrations observed at other doses.
- Conditions
- Healthy
- Being tested
- Sandimmun® IV, CyCol® capsules
- Keywords
- Cyclosporine, Healthy Volunteers, Immunosuppressive Agents, CyCol, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandimmun® IVDrug
Also called Cyclosporine A, Sandimmun® concentrate for solution for Infusion
2 mg/kg IV
CyCol® capsulesDrug
Also called Cyclosporine A, oral cyclosporine
37.5 mg CyCol® capsules
| Study group | Role | What they receive |
|---|---|---|
| Sandimmun® IV | Active comparator | Sandimmun® IV 2mg/kg as a 24 hour infusion (2mg/kg/day) Receives: Drug: Sandimmun® IV |
| CyCol® capsules | Experimental | CyCol®: 75 mg OD \& BID for 7 days Receives: Drug: CyCol® capsules |
| CyCol® capsules 37.5 mg | Experimental | CyCol®: 37.5 mg OD or BID for 7 days Receives: Drug: CyCol® capsules |
| CyCol® capsules, 150 mg | Experimental | CyCol®: 150 mg OD or BID for 7 days Receives: Drug: CyCol® capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables for cyclosporine (in whole blood)
Area under the concentration-time curve (AUC) from;
- time zero to the last non-zero concentration (AUC 0-t),
- time zero extrapolated to infinity (AUC 0-inf),
- maximum observed concentration (Cmax)
Measured: Day 1 and Day 7
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N) in colonic mucosa
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N)in colonic mucosal tissue
Measured: Day 2 or Day 7
Secondary outcomes (1)
Safety and Tolerability of CyCol
Percentage of subjects with clinically significant abnormal results
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigmoid Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sigmoid Pharma, Study director, Sigmoid Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130414
- Sponsor's protocol ID
- CYC102
- Acronym
- CYC102
- Status last verified
- May 2015
- First submitted
- 22 Apr 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose, Multi-stage Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Colon Tissue Distribution of Cyclosporine Capsules (CyCol®) Compared to Intravenous Cyclosporine in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02130414
- Acronym / sponsor ID
- CYC102 / CYC102
- Conditions
- Healthy
- Keywords
- Cyclosporine, Healthy Volunteers, Immunosuppressive Agents, CyCol, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sigmoid PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 May 2014 (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 aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.
Detailed description
This is an open label, multiple-dose, multi-stage pharmacokinetic (PK) study. A maximum of 40 healthy adult male volunteers aged between 18 and 55 years will be enrolled at a single clinical research unit.
For each CyCol® group dosing will last 7 days, whilst the Sandimmun® IV group will have a single dose over 24 hours.
Single dose pharmacokinetics of different doses of CyCol® will be compared to IV Sandimmun®. In addition colonic tissue concentrations will be compared after multiple doses of CyCol® to a single IV dose of Sandimmun®. Concentrations of unchanged cyclosporine and it's metabolites in the faeces will also be explored.
Stage 1 of the study will investigate the 75mg dose (OD and BID) of CyCol® and IV Sandimmun®. Then dependent on results Stages 2 and 3 will investigate either lower (37.5mg) or higher (150mg) dose levels. The dosing regimens chosen for Stages 2 and 3 will be based upon safety and tolerability, systemic exposure and colonic mucosa tissue concentrations observed at other doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sandimmun® IV | Active comparator | Drug: Sandimmun® IVSandimmun® IV 2mg/kg as a 24 hour infusion (2mg/kg/day) |
| CyCol® capsules | Experimental | Drug: CyCol® capsulesCyCol®: 75 mg OD \& BID for 7 days |
| CyCol® capsules 37.5 mg | Experimental | Drug: CyCol® capsulesCyCol®: 37.5 mg OD or BID for 7 days |
| CyCol® capsules, 150 mg | Experimental | Drug: CyCol® capsulesCyCol®: 150 mg OD or BID for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers, between the ages of 18 and 55 years, inclusive.
- Mass Index (BMI) of 18.5 to 30.0 kg/m2, inclusive; and a total body weight >50 kg (110 lbs).
- Subjects capable of providing written consent.
- Subjects willing to use acceptable method of contraception starting from the first dose and continuing for at least 3 months after the last dose of study drug.
- Subjects who are willing and able to comply with scheduled visits, dosing plan, laboratory tests, and other study procedures.
Key exclusion criteria (23 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of significant drug abuse
- History of regular alcohol consumption
- Treatment with an investigational drug within 90 days prior to first dose of study medication.
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 |
|---|---|---|
| Sandimmun® IVAlso: Cyclosporine A, Sandimmun® concentrate for solution for Infusion2 mg/kg IV | Drug | Sandimmun® IV |
| CyCol® capsulesAlso: Cyclosporine A, oral cyclosporine37.5 mg CyCol® capsules | Drug | CyCol® capsules, CyCol® capsules 37.5 mg, CyCol® capsules, 150 mg |
Primary outcome
Pharmacokinetic variables for cyclosporine (in whole blood)
Time frame: Day 1 and Day 7
Area under the concentration-time curve (AUC) from; * time zero to the last non-zero concentration (AUC 0-t), * time zero extrapolated to infinity (AUC 0-inf), * maximum observed concentration (Cmax)
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N) in colonic mucosa
Time frame: Day 2 or Day 7
Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N)in colonic mucosal tissue
1 secondary outcome
Safety and Tolerability of CyCol
Time frame: Day 1 to Day 7
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 19 May 2015.
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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.
Sigmoid Pharma study director
Sigmoid Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sandimmun® IV and CyCol® capsules in people with Healthy, run by Sigmoid Pharma.
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 6 inclusion and 23 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 19 May 2015. 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?
Pharmacokinetic variables for cyclosporine (in whole blood) (time frame: Day 1 and Day 7). 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?
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 19 May 2015.