Healthy SubjectsPhase 1NCT02993055
A Study to Assess Ulimorelin in Healthy Subjects
A Phase 1 study testing Ulimorelin in people with Healthy Subjects, run by Lyric Pharmaceuticals.
Trial summary
A Phase I dose escalation study involving 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 Subjects
- What is being tested?
- Ulimorelin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 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
- Ethics committee approved written informed consent and privacy language per national regulations must be obtained from the subject before any study-related procedures (including withdrawal of prohibited medication, if applicable)
- Subject is a healthy male or non-pregnant (as documented by a negative urine pregnancy test at screening and admission to the clinical study unit on Day -1 of the SAD phase and Day -3 of MAD phase), non-lactating healthy female who is aged between 18 and 55 years, inclusive, weighs between 50 kg to 90 kg, and has a body mass index in the range of 18 to 35 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Subject is a non-smoker and has not used tobacco for a minimum of 6 months before screening (a breath carbon monoxide reading of ≤10 ppm at screening)
- Subject must be willing and able to communicate and participate in the whole study
- Must agree to use an adequate method of contraception
Who cannot join
- Subject has clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator at screening or admission as determined by the investigator
- Subject has abnormal and clinically significant 12-lead ECG at screening or on admission to the clinical study unit at each period
- Subject has 12-lead ECG demonstrating QTcF >450 msec in males and >470 msec in females at screening. If QTcF exceeds these limits, the ECG should be repeated 2 more times at least 1 minute apart, and the average of the 3 QTcF values should be used to determine the subject's eligibility
- Subject has a known serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subject has supine blood pressure or pulse rate outside of the ranges 90 to 140 mmHg systolic blood pressure/40 to 90 mmHg diastolic blood pressure and 50 to 90 bpm, respectively, at screening or admission or a heart rate below 46 bpm at pre-dose on Day 1 of either the SAD or MAD phase
Show all 21Show fewer
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 2 g per day paracetamol) or herbal remedies in the 7 days before IMP administration
- Subject has received a vaccine within 30 days before first dosing
- Subject has a history of drug or alcohol abuse within the past 2 years before screening or a positive result for alcohol at screening or admission
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 1⁄2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Positive drugs of abuse test result
- Subject has a history of any clinically significant neurological, GI (especially prior gastric or oesophageal surgery, gastroparesis, peptic ulceration, GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome), renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine (diabetes mellitus), respiratory or haematological disorder or disease or any other medical condition that, in the opinion of the investigator, would preclude participation in the study
- Subject has participated in another investigational study within the past 3 months before study drug administration, or subject has previously participated in a study with ulimorelin
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- History of upper GI surgery
- Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- Subject has any other condition that in the opinion of the investigator precludes participation in the trial
About this study
Official title: A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ulimorelin (LP101)
A Phase I dose escalation study involving healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Ulimorelin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlimorelinDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Ulimorelin | Experimental | Active Receives: Drug: Ulimorelin |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the Cmax after administration of Ulimorelin
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 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 Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyric Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993055
- Sponsor's protocol ID
- LP101-CL-101
- Status last verified
- May 2018
- First submitted
- 7 Dec 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Individual data sharing
- No
Publications
James J, Mair S, Doll W, Sandefer E, Wurtman D, Maurer A, Deane AM, Harris MS. The effects of ulimorelin, a ghrelin agonist, on liquid gastric emptying and colonic transit in humans. Neurogastroenterol Motil. 2020 Mar;32(3):e13784. doi: 10.1111/nmo.13784. Epub 2020 Feb 3.
PubMed 32017341
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ulimorelin (LP101)
- ClinicalTrials.gov ID
- NCT02993055
- Acronym / sponsor ID
- LP101-CL-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Lyric PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Dec 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.
A Phase I dose escalation study involving healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulimorelin | Experimental | Drug: UlimorelinActive |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ethics committee approved written informed consent and privacy language per national regulations must be obtained from the subject before any study-related procedures (including withdrawal of prohibited medication, if applicable)
- Subject is a healthy male or non-pregnant (as documented by a negative urine pregnancy test at screening and admission to the clinical study unit on Day -1 of the SAD phase and Day -3 of MAD phase), non-lactating healthy female who is aged between 18 and 55 years, inclusive, weighs between 50 kg to 90 kg, and has a body mass index in the range of 18 to 35 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Subject is a non-smoker and has not used tobacco for a minimum of 6 months before screening (a breath carbon monoxide reading of ≤10 ppm at screening)
- Subject must be willing and able to communicate and participate in the whole study
- Must agree to use an adequate method of contraception
Key exclusion criteria (21 listed)
- Subject has clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator at screening or admission as determined by the investigator
- Subject has abnormal and clinically significant 12-lead ECG at screening or on admission to the clinical study unit at each period
- Subject has 12-lead ECG demonstrating QTcF >450 msec in males and >470 msec in females at screening. If QTcF exceeds these limits, the ECG should be repeated 2 more times at least 1 minute apart, and the average of the 3 QTcF values should be used to determine the subject's eligibility
- Subject has a known serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
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 |
|---|---|---|
| Ulimorelin | Drug | Ulimorelin |
| Placebo | Other | Placebo |
Primary outcome
Measuring the Cmax after administration of Ulimorelin
Time frame: 7 days
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 30 May 2018.
- Derived from this study: PubMed 32017341James J, Mair S, Doll W, Sandefer E, Wurtman D, Maurer A, Deane AM, Harris MS. The effects of ulimorelin, a ghrelin agonist, on liquid gastric emptying and colonic transit in humans. Neurogastroenterol Motil. 2020 Mar;32(3):e13784. doi: 10.1111/nmo.13784. Epub 2020 Feb 3.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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 Ulimorelin in people with Healthy Subjects, run by Lyric Pharmaceuticals.
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 5 inclusion and 21 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 30 May 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. 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?
Measuring the Cmax after administration of Ulimorelin (time frame: 7 days). 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 NCT02993055, 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 30 May 2018.