Ulcerative ColitisPhase 1NCT02818543
Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis
A Phase 1 study testing LYC-30937 in people with Ulcerative Colitis, run by Lycera Corp. at 2 sites in Hungary.
Trial summary
The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LYC-30937
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesHungary
- Study dates
- Mar 2016to Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy.
- Male or female age 18 to 75
- May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy
Who cannot join
- Current anti-tumor necrosis factor use
- Current immunosuppressant use (Note: this does not include corticosteroid use)
- Subjects with only distal active disease (i.e. proctitis)
- Clinically significant active infection
- Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required
- History of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ
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- Clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin)
- History of colon resection
- Any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis
The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.
- Conditions
- Ulcerative Colitis
- Being tested
- LYC-30937
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYC-30937Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | LYC-30937 25 mg single oral dose Receives: Drug: LYC-30937 |
| Cohort 2 | Experimental | LYC-30937 100 mg single oral dose Receives: Drug: LYC-30937 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
Measured: up to 48 hours
Time to maximum observed plasma concentration (Tmax)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Measured: up to 48 hours
Percentage of estimated Area Under the Curve (0-inf)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Measured: up to 48 hours
Secondary outcomes (4)
Treatment emergent adverse events (TEAEs)
TEAEs will be listed and summarized by dose and overall
Measured: 7 days post-dose
Clinical laboratory data
Clinical laboratory data will be listed with flagging of values outside the normal range
Measured: 7 days post-dose
Vital signs
descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time
Measured: 7 days post-dose
12-Lead Electrocardiogram (ECG)
Descriptive statistics will be provided to summarize ECG parameters
Measured: 7 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lycera Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818543
- Sponsor's protocol ID
- LYC-30937-1002
- Status last verified
- Dec 2016
- First submitted
- 30 Mar 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02818543
- Acronym / sponsor ID
- LYC-30937-1002
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lycera Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Jun 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 purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: LYC-30937LYC-30937 25 mg single oral dose |
| Cohort 2 | Experimental | Drug: LYC-30937LYC-30937 100 mg single oral dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy.
- Male or female age 18 to 75
- May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy
Key exclusion criteria (9 listed)
- Current anti-tumor necrosis factor use
- Current immunosuppressant use (Note: this does not include corticosteroid use)
- Subjects with only distal active disease (i.e. proctitis)
- Clinically significant active infection
- Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required
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 |
|---|---|---|
| LYC-30937 | Drug | Cohort 1, Cohort 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
Time to maximum observed plasma concentration (Tmax)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Percentage of estimated Area Under the Curve (0-inf)
Time frame: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
4 secondary outcomes
Treatment emergent adverse events (TEAEs)
Time frame: 7 days post-dose
Clinical laboratory data
Time frame: 7 days post-dose
Vital signs
Time frame: 7 days post-dose
12-Lead Electrocardiogram (ECG)
Time frame: 7 days post-dose
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 14 Dec 2016.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYC-30937 in people with Ulcerative Colitis, run by Lycera Corp. at 2 sites in Hungary.
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 3 inclusion and 9 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum observed plasma concentration (Cmax) (time frame: up to 48 hours). The study lists 3 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 14 Dec 2016.