LEO 152020 tablet
Drugfilm-coated tablet
NCT Number: NCT04203836
A phase 1 trial in healthy people to evaluate the food effect on LEO 152020 in an open-label design using film-coated tablets
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
LEO Pharma Investigational Site, Leeds, United Kingdom
This trial will evaluate the pharmacokinetics and tolerability of 2 single doses of film-coated tablets in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key inclusion Criteria:
Key exclusion Criteria:
film-coated tablet
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Maximum observed plasma concentration
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)
Time frame: Baseline to Day 10
Number of AEs per subject at each combination of treatment and in total
Time frame: Baseline to Day 10
Clinically relevant changes in resting blood pressure (mmHq)
Time frame: Baseline to Day 10
Clinically relevant changes in pulse (beats per minute)
Time frame: Baseline to Day 10
Clinically relevant changes in oral body temperature (fahrenheit/celsius)
Time frame: Baseline to Day 10
Clinically relevant abnormalities in any chemistry laboratory parameters tested (standard units): Sodium, potassium, creatinine, creatine phosphokinase, urea nitrogen, calcium , alkaline phosphatase , aspartate aminotransferase , alanine aminotransferase , gamma glutamyl transferase , bilirubin, lactate dehydrogenase, cholesterol, triglycerides, glucose (fasting), albumin, protein, or tryptase
Time frame: Baseline to Day 10
Clinically relevant abnormalities in any haematology laboratory parameter tested (standard units): erythrocytes, hematocrit, hemoglobin, or white blood cells
Time frame: Baseline to Day 10
Clinically relevant laboratory abnormalities in any urinalysis parameters (standard units): protein, glucose, ketones, occult blood, leukocytes, or nitrite
Time frame: Baseline to Day 10
Abnormal ECGs (maximum QTcF interval of ≥450 msec, or maximum change from baseline of ≥60 msec)
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Area under the plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUC0 inf)
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Time to maximum plasma concentration
Time frame: pre-dose to 48 hours of each treatment period (Day 1 and Day 8)
Terminal elimination half life
JW Pharmaceutical
Industry
A Phase 1, Randomised, Oral Dose Trial to Evaluate the Effect of Food on LEO 152020 in Healthy Adult Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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