A Study to Assess Ulimorelin in Healthy Subjects

NCT02993055 | Completed Phase 1

• 1 other identifier: LP101-CL-101
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase I dose escalation study involving healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Measuring the Cmax after administration of Ulimorelin

  7 days

Study Arms (2)

Ulimorelin

EXPERIMENTAL

Active

Drug: Ulimorelin

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Ulimorelin DRUG

Ulimorelin

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lyric Pharmaceuticals: lead

Related Publications (1)

• 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.

  PMID: 32017341 DERIVED

MeSH Terms

Interventions

ulimorelin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 14, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share