![]() Secondary analysis using the Per Protocol Population will also be performed. The analysis of study endpoints will be performed using the ITT participant population. Positive results for urine drugs of abuse screen or alcohol breath test at screeningġ2.Ěny illegal or non-approved recreational drug use during the last six months. History of prolonged QT interval, or prolonged QTcF interval at screening, defined as QTcF >450 msec (the average of the triplicate should be used to assess QTcF).ġ1. Use of any investigational drug within 30 days of dosing, or planned use of another investigational drug during the course of this studyġ0. more than 2 cigarettes per day in the last 12 months)ħ.Ěny prescribed medications within 14 days prior to the first dose of study medicationĨ.Ěny over-the-counter medications/herbal remedies/vitamins/supplements within 7 days prior to first dose of study medicationĩ. Raised blood pressure (systolic >140 mmHg or diastolic >95 mmHg)Ħ.Ĝurrent or previous clinically significant smoking history (i.e. Haemoglobin or haematocrit below the laboratory reference rangeĥ. Infection or febrile illness within 5 days prior to first doseĤ. ![]() Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C ģ. The following pharmacokinetic parameters for NRP2945 will be derived for the SAD dose group:ġ.Ĝlinically significant co-existing disease or condition in the opinion of the Investigator (example of an allowable condition is hay fever that does not require regular medication).Ģ. MAD cohorts: :Screening visit,, Day 1 visit (pre-dose) and on Days 1, and 9 and 21 visits (pre-dose and 15-25 min and 60-70min post-dose)įor the 25 microgram/kg dose, blood samples will be collected at the following time-points: pre-dose, 5, 10, 15, 20, 30, 45 and 60 minutes post-dose. ![]() MAD cohorts: screening visit, Day -1 and follow up visit (Day 29-32)ĮCG: SAD cohorts: Screening visit, prior to dosing 15-25 min and 60-70min post-dose (Day 1 visit) Weight: SAD cohorts: screening visit, Day -1 and follow up visit (Day 3-6) SAD cohorts: Screening visit, Day -1 visit, Day 1, Day 2 and follow-up visit (Day 3-6), SAD cohorts: screening visit, Day -1 visit, Day 2 and follow-up visit (Day 3-6) Laboratory tests: haematology, clinical chemistry and urinalysis: MAD cohorts: Day 1 to Day 4 (continuous monitoring) and at visits on Days 5, 7, 9, 11, 13, 15, 17, 19, 21, 23,25, 27 and at the follow up visit (day 29-32) SAD cohorts: Day 1 to Day 2 (24 hrs) continuous monitoring and at follow-up visit (day 3-6) Adverse events (including serious adverse events): from randomisation until the follow-up visit. ![]()
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