A Study of NPC-22 in Healthy Adult Males

Healthy Adult Subjects Clinical Trial

Official title:

A Phase 1 Single Ascending Dose Study of NPC-22 in Healthy Adult Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203862
• Other study ID #: NPC-22
• Status: Completed
• Phase: Phase 1
• Start date: November 19, 2019
• Est. completion date: February 4, 2020

Study information

• Verified date: August 2020
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to examine the safety and pharmacokinetics of NPC-22 administered in a single ascending dose in healthy adult males.

Description:

The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Subjects who have provided their own written informed consent

2. Subjects aged =20 and <40 years at the time of informed consent

3. Subjects with body weight of =50 kg and body mass index (BMI) (kg/m2) of =18.5 and <25.0

4. Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

Exclusion Criteria:

1. Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence

2. Subjects with a history of severe disease that may recur during the study period

3. Subjects with any concurrent illnesses

4. Subjects who received another study drug within 180 days prior to the start of study drug administration

5. Subjects who donated blood of =400 mL within 12 weeks, blood of =200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study

6. Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration

7. Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration

8. Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration

9. Subjects who smoked within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period

10. Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening

11. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening [e.g., Fridericia's corrected QT (QTcF) interval of =450 ms]

12. Subjects who have a familial history of torsades de pointes or long QT syndrome

13. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values

14. Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• NPC-22
Single administration of low dose NPC-22
• NPC-22
Single administration of low/middle dose NPC-22
• NPC-22
Single administration of middle dose NPC-22
• NPC-22
Single administration of middle/high dose NPC-22
• NPC-22
Single administration of high dose NPC-22
• NPC-22 Placebo
Single administration of NPC-22 Placebo

Locations

Country	Name	City	State
Japan	Medical Corporation Shinanokai Shinanozaka Clinic	Shinjuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-7 days post dose
Primary	Body temperature	Body temperature will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Primary	Blood pressure	Blood pressure will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Primary	Pulse rate	Pulse rate will be measured for assess the safety of single ascending dose of NPC-22	0-7 days post dose
Primary	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	0-7 days post dose
Primary	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	0-7 days post dose
Primary	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	0-7 days post dose
Primary	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	0-7 days post dose
Secondary	Observed plasma concentration		0-7 days post dose
Secondary	Observed urine concentration		0-4 days post dose