Digestive System DisordersPhase 1NCT01405599
Evaluation of the Pharmacokinetics of Ulimorelin in Subjects With Hepatic Impairment and Healthy Subjects
A Phase 1 study testing Ulimorelin in people with Digestive System Disorders, run by Norgine at 1 site in Slovakia.
Trial summary
Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to determine whether their dosage should be adjusted. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System Disorders
- What is being tested?
- Ulimorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSlovakia
- Study dates
- Jun 2011to Oct 2011
- 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
- Main Criteria for Inclusion All Subjects:
- Adult male or female subjects age 18 to 75 years (both inclusive)
- Able to understand and willing to sign an informed consent form (ICF) and able to comply with the study restrictions
- Female subjects must be postmenopausal (for at least 1 year and confirmed by serum follicle-stimulating hormone (FSH) at screening), surgically sterile, practicing true abstinence and/or must be using adequate contraception for the duration of the study (e.g. contraceptive implants, injectables, oral contraceptives, and intra-uterine device and/or barrier methods (condom/occlusive cap with spermicidal foam/gel/film/cream/suppository))
- Females of childbearing potential must have a negative pregnancy test at screening and Day -1
- Weight ≥ 50 kg and ≤ 200 kg
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- Body mass index (BMI) ≤ 40.0 kg/m2, where BMI (kg/m2) = Body weight (kg)/Height2 (m2) Inclusion Criteria Hepatic Impairment Subjects (in addition to the criteria for all subjects):
- Documented mild, moderate or severe hepatic impairment defined as either Child-Pugh A, B or C at screening
- Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days before screening, as documented by the subject's recent medical history (e.g., no worsening of clinical signs of hepatic impairment and no worsening of total bilirubin or prothrombin time by more than 50%)
- Must be on a stable dose of medication and/or treatment regimen at least 2 weeks before dosing of study medication
- Subjects with a history of substance abuse may be enrolled provided that they have not abused drugs or alcohol for at least 6 months preceding the study Inclusion Criteria for Healthy Subjects (in addition to criteria for all subjects):
- Subjects with normal hepatic function, and liver parameters within normal range unless approved by the Sponsor's Medical Representative
- Subjects not using prescription drugs or non-prescription drugs, including over-the-counter medication, non-routine vitamins and herbal products within 3 weeks prior to dosing of investigational product [use of oral contraceptives, diuretics, noncardioselective beta-blockers, topically applied medication (eye-/nose-drops and creams) and occasional use of metaclopramide, ibuprofen and paracetamol is permitted]. Use of any other medication has to be discussed and agreed before inclusion of the subject with the Medical Monitor and the Sponsor's medical representative
Who cannot join
- Criteria for Exclusion All Subjects:
- Known or suspected allergy to the trial product or related products
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half life of the drug if longer)
- Acute illness within 14 days prior to dosing unless mild in severity and approved by the Investigator and Sponsor's medical representative
- History of drug abuse or positive urine drug screen (if not due to concomitant medication) at Screening and/or Day -1
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- Ingestion of alcohol and caffeine within 24 hours prior to dosing and for the duration of the study
- Donation of more than 450mL of blood / blood products in the 30 days prior to dosing, and/or blood donation in the 30 days prior to dosing
- Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen according to locally used diagnostic testing
- Creatinine clearance <50mL/minute, estimated using serum creatinine with the formula [(140 - age in years) × weight in kg]/[(72 × serum creatinine in mg/dL) × 0.85 for female subjects]
- Consumption of Seville oranges, grapefruit or grapefruit juice, star fruit and exotic fruits from 7 days prior to first dose of study medication and for entire duration of the study
- Clinically significant abnormal haematology, biochemistry, coagulation or urinalysis screening tests, as judged by the Investigator other than the abnormal values expected considering the underlying disease
- Subject with any disease or condition which the Investigator feels would interfere with the trial outcome or compliance except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and /or diastolic blood pressure ≥ 105 mmHg)
- Use of prescription or over-the-counter medication that is extensively bound to α1-acid glycoprotein (AAG) which the Investigator or Sponsor feels would interfere with the trial outcome
- History of cancer (judged not to be in full remission) or presence of cancer (except basal cell skin cancer or squamous cell skin cancer) as judged by the Investigator
- Subject who has undergone liver transplantation
- Not able or willing to refrain from smoking during the inpatient period
- Any condition that would make the subject unsuitable for clinical trial participation as judged by the Investigator
- Exclusion Criteria Hepatic Impairment Subjects (in addition to criteria for all subjects):
- Any medical or surgical conditions, excluding underlying liver disease, which may significantly interfere with the pharmacokinetics of the study drug
- Fluctuating or rapidly deteriorating hepatic function
- Exclusion Criteria for Healthy Subjects (in addition to criteria for all subjects):
- Subjects with clinically significant illness as judged by the Investigator
- Exposure to more than three new chemical entities within 12 months prior to the first dosing day
- Known acute hepatitis with viral, alcoholic, toxic or autoimmunological aetiology within the last 6 months. Positive result to the screening test for Hepatitis B antigen or Hepatitis C antibodies according to locally used diagnostic testing
- Strenuous exercise within 48 hours prior to dosing and for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ulimorelin in Subjects With Mild, Moderate and Severe Hepatic Impairment, in Comparison With Healthy Subjects
Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to determine whether their dosage should be adjusted.
- Conditions
- Digestive System Disorders
- Being tested
- Ulimorelin
- Keywords
- Ulimorelin, Hepatic Impairment
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlimorelinDrug
Also called TZP101
Single dose of 480 micrograms/kg administered as a 30 minute intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Healthy subjects Receives: Drug: Ulimorelin |
| Severe hepatic impairment | Experimental | CTP class C Receives: Drug: Ulimorelin |
| Moderate hepatic impairment | Experimental | CTP class B Receives: Drug: Ulimorelin |
| Mild hepatic impairment | Experimental | CTP class A Receives: Drug: Ulimorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of ulimorelin
To evaluate the pharmacokinetics of ulimorelin in subjects with mild, moderate and severe hepatic impairment compared with subjects who have normal hepatic function following a single dose administration of ulimorelin
Measured: 15, 30, 45, 60, 75, 90 mins, 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 h post-infusion
AUC of ulimorelin
To evaluate the pharmacokinetics of ulimorelin in subjects with mild, moderate and severe hepatic impairment compared with subjects who have normal hepatic function following a single dose administration of ulimorelin
Measured: 15, 30, 45, 60, 75, 90 mins, 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 h post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DisordersStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Tomas, PhD, Study director, Norgine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405599
- Sponsor's protocol ID
- NPJ5004-01/2011 (HEP)
- Status last verified
- Oct 2012
- First submitted
- 22 Jul 2011
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ulimorelin in Subjects With Mild, Moderate and Severe Hepatic Impairment, in Comparison With Healthy Subjects
- ClinicalTrials.gov ID
- NCT01405599
- Acronym / sponsor ID
- NPJ5004-01/2011 (HEP)
- Conditions
- Digestive System Disorders
- Keywords
- Ulimorelin, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Jul 2011 (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.
Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to determine whether their dosage should be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: UlimorelinHealthy subjects |
| Severe hepatic impairment | Experimental | Drug: UlimorelinCTP class C |
| Moderate hepatic impairment | Experimental | Drug: UlimorelinCTP class B |
| Mild hepatic impairment | Experimental | Drug: UlimorelinCTP class A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult male or female subjects age 18 to 75 years (both inclusive)
- Able to understand and willing to sign an informed consent form (ICF) and able to comply with the study restrictions
- Female subjects must be postmenopausal (for at least 1 year and confirmed by serum follicle-stimulating hormone (FSH) at screening), surgically sterile, practicing true abstinence and/or must be using adequate contraception for the duration of the study (e.g. contraceptive implants, injectables, oral contraceptives, and intra-uterine device and/or barrier methods (condom/occlusive cap with spermicidal foam/gel/film/cream/suppository))
- Females of childbearing potential must have a negative pregnancy test at screening and Day -1
- Weight ≥ 50 kg and ≤ 200 kg
Key exclusion criteria (27 listed)
- Known or suspected allergy to the trial product or related products
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half life of the drug if longer)
- Acute illness within 14 days prior to dosing unless mild in severity and approved by the Investigator and Sponsor's medical representative
- History of drug abuse or positive urine drug screen (if not due to concomitant medication) at Screening and/or Day -1
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 |
|---|---|---|
| UlimorelinAlso: TZP101Single dose of 480 micrograms/kg administered as a 30 minute intravenous infusion | Drug | Control, Mild hepatic impairment, Moderate hepatic impairment, Severe hepatic impairment |
Primary outcome
Cmax of ulimorelin
Time frame: 15, 30, 45, 60, 75, 90 mins, 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 h post-infusion
To evaluate the pharmacokinetics of ulimorelin in subjects with mild, moderate and severe hepatic impairment compared with subjects who have normal hepatic function following a single dose administration of ulimorelin
AUC of ulimorelin
Time frame: 15, 30, 45, 60, 75, 90 mins, 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 h post-infusion
To evaluate the pharmacokinetics of ulimorelin in subjects with mild, moderate and severe hepatic impairment compared with subjects who have normal hepatic function following a single dose administration of ulimorelin
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 16 Oct 2012.
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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.
Maria Tomas, PhD study director
Norgine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ulimorelin in people with Digestive System Disorders, run by Norgine at 1 site in Slovakia.
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 13 inclusion and 27 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 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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?
Cmax of ulimorelin (time frame: 15, 30, 45, 60, 75, 90 mins, 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 h post-infusion). 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 16 Oct 2012.