A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ulimorelin (LP101)

Lyric Pharmaceuticals0 sites39 target enrollmentJanuary 2015

ConditionsHealthy Subjects

InterventionsUlimorelin Placebo

DrugsUlimorelin

Overview

Phase: Phase 1
Intervention: Ulimorelin
Conditions: Healthy Subjects
Sponsor: Lyric Pharmaceuticals
Enrollment: 39
Primary Endpoint: Measuring the Cmax after administration of Ulimorelin
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A Phase I dose escalation study involving healthy subjects.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

November 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lyric Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•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