AzTrials
AzTrials

Digestive System DisordersPhase 1NCT01405612

Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam in Healthy Volunteers

A Phase 1 study testing Midazolam and Ulimorelin in people with Digestive System Disorders, run by Norgine at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

An open-label, single centre, randomised, cross-over study to examine the effect of ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of ulimorelin in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Digestive System Disorders
What is being tested?
Midazolam and Ulimorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2011to Jul 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male or female volunteers (as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead ECGs at screening) aged 18 to 45 years.
  • Non-smokers from three months before receiving the first dose of study drug and for the duration of the study.
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
  • Body weight ≥ 50 kg and ≤ 120 kg at screening.
  • Able to voluntarily provide written informed consent to participate in the study.
  • Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
Show all 13Show fewer
  • Female volunteers must be postmenopausal (for at least one year and confirmed by serum follicle stimulating hormone (FSH) at screening), surgically sterile, practising true sexual abstinence, or must use two highly effective methods of contraception (defined as a failure rate of less than 1% per year when used consistently and correctly) throughout the study until after post-study medical as follows: contraceptive implants, injectables, oral contraceptives, some intrauterine devices (IUDs), vasectomised partner and / or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository.
  • Hormonal and IUD methods of contraception must be established for a period of three months prior to dosing and cannot be changed or altered during the study.
  • Females of childbearing potential must have a negative serum pregnancy test at screening (β-hCG) and a negative urine pregnancy test at check-in for each period.
  • Sexually active male volunteers must use condoms with their partners throughout the study and for 90 days after completion of the study in addition to their partner's normal mode of contraception.
  • Male volunteers must not donate sperm during the study and for 90 days after completion of the study.
  • Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
  • The volunteer's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical study.

Who cannot join

  • Subjects with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or current infection.
  • Pregnant or lactating females.
  • Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator, or a value of alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 10% of the upper limit of the reference range.
  • Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  • Current or history of drug or alcohol abuse or a positive drugs of abuse test at screening or check-in.
  • Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
Show all 14Show fewer
  • Any significant illness during the screening period preceding entry into this study.
  • Donation of blood or blood products within 90 days prior to study drug administration, or at any time during the study, except as required by this protocol or haemoglobin < 12.0 g/dl at screening.
  • Subjects who have received monoamine oxidase inhibitors or who have been on a special diet as assessed by the Investigator within 28 days of starting the study or during the study.
  • Subjects who have a history or presence of any significant drug allergy, or a known allergy or contraindication to midazolam or other benzodiazepines.
  • Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 28 days prior to study drug administration until the end of the study, with the exception of Investigator-approved hormonal contraceptives, hormone replacement therapy (HRT) and occasional paracetamol.
  • Use of any known inhibitors or inducers (e.g. St. John's Wort) of CYP3A4 within 28 days or 5 half lives prior to study drug administration, whichever is longer, until the end of the study.
  • Use of grapefruit juice or grapefruit containing products within 7 days prior to study drug administration until the end of the study.
  • Strenuous exercise, as judged by the Investigator, within 72 hours prior to screening, within 72 hours prior to study drug administration and for the duration of the study (until post-study medical).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • BioKinetic Europe Ltd

    Belfast, BT2 7BA

Other trials in United Kingdom

About this study

Official title: An Open-label, Single Centre, Randomised, Cross-over Study to Examine the Effect of Ulimorelin on the Pharmacokinetics of Midazolam After Repeat Dose Administration of Ulimorelin in Healthy Volunteers

An open-label, single centre, randomised, cross-over study to examine the effect of ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of ulimorelin in healthy volunteers.

Read the detailed description

Ulimorelin is a first-in-class new chemical entity. It is a ghrelin agonist with gastroprokinetic activity being developed as an intravenous therapy to be used in the treatment of gastrointestinal (GI) hypomotility disorders such as post-operative ileus (POI) and gastroparesis.

POI is a transient disruption of co-ordinated bowel motility that contributes to patient morbidity, discomfort and prolonged recovery times. POI most commonly occurs after abdominal surgery and annually, POI is the main determinant of length of hospital stay after major abdominal surgery and a factor in patient hospital re-admissions, increased healthcare resource use and cost, and decreased patient satisfaction. Current strategies to attenuate POI are aimed at enhanced recovery after surgery (ERAS) or "fast track". These are multimodal care protocols designed to reduce the impact of external and internal factors on POI duration. Recently, fewer complications and a quicker return to work and normal activities for patients who have had ERAS programmes implemented have been reported. In spite of these strategies only up to 20% of subjects undergoing partial bowel resection recover GI function within 72 hours after surgery.

Being tested
Midazolam, Ulimorelin
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.

  • MidazolamDrug

    Single oral administration on Day 1 or Day 5

  • UlimorelinDrug

    Also called TZP101

    Intravenous infusion of 480 micrograms/kg on Days 1 to 5

Study groups in NCT01405612
Study groupRoleWhat they receive
MidazolamExperimentalThose subjects to receive Treatment A will receive a single dose of midazolam on Day 1 and will be discharged from the study unit on Day 2, at least 30 hours after midazolam dosing.
Receives: Drug: Midazolam
UlimorelinExperimentalThose subjects to receive Treatment B will receive once daily ulimorelin on Days 1 to 5. Midazolam will be administered on Day 5 with the last dose of ulimorelin and subjects will be discharged from the study unit on Day 6, at least 30 hours after midazolam dosing.
Receives: Drug: Ulimorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0 to infinity) of midazolam

    Measured: Pre-(midazolam)dose and 15, 30, 45 mins and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 30 hours post dose

  2. Cmax of Midazolam

    Measured: Pre-(midazolam)dose and 15, 30, 45 mins and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 30 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01405612
Sponsor's protocol ID
NPJ5004-02/2011 (DDI)
Status last verified
Oct 2012
First submitted
22 Jul 2011
Last updated
16 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam and Ulimorelin in people with Digestive System Disorders, run by Norgine at 1 site in United Kingdom.

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 14 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 United Kingdom. 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?

AUC(0 to infinity) of midazolam (time frame: Pre-(midazolam)dose and 15, 30, 45 mins and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 30 hours post dose). 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?

On the ClinicalTrials.gov record for NCT01405612.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in