A Phase 1 interventional study of NPC-22 and NPC-22 in Safety and Pharmacokinetics, sponsored by Nobelpharma. Completed at 1 site in Japan. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-07.
Sponsored by Nobelpharma · Phase 1, Interventional, and Basic science
The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22 administration in healthy adult males.
The effect of administration routes for pharmacokinetics will be examined in advance.
Nobelpharma is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Japanese individuals who have been confirmed to meet all of the following criteria will be enrolled as a subject:
Exclusion Criteria:
Japanese Individuals who meet any of the following criteria will be excluded from the study:
Single administration of middle dose NPC-22
Drug: NPC-22
Single administration of high dose NPC-22
Drug: NPC-22
Single administration of placebo dose NPC-22
Drug: NPC-22 Placebo
Single administration of middle dose NPC-22
Single administration of high dose NPC-22
Single administration of NPC-22 Placebo
Adverse events
An adverse event will refer to any unfavorable or unintended sign (including an abnormal laboratory finding and abnormality on the 12-lead ECG or in vital signs) and symptom
Time frame: 0-14 days post dose
Body temperature
Body temperature will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Blood pressure
Blood pressure will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Pulse rate
Pulse rate will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
ECG
RR, PR, QRS, QT and QTcF interval and heart rate will be measured for assess the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
Hematology tests will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
Blood chemistry tests will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
Urinalysis will be performed for assessment the safety of single ascending dose of NPC-22
Time frame: 0-14 days post dose
Observed plasma concentration
Time frame: 0-14 days post dose
Observed urine concentration
Time frame: 0-14 days post dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Nobelpharma