Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults

The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults

Study Overview

• Status: Completed
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: sirolimus

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Matsudo, Chiba, Japan, 270 -2231
      • Clinique Soigner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Japanese healthy subjects aged 20 to 39 years of age
2. Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
3. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
4. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
5. Subjects who write informed consent
6. Subjects who are able to comply with the study requirements during the study period

Exclusion Criteria:

1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
2. Subjects who have a history of hypersensitivity or allergies to other drug
3. SUbjects who have an acute or chronic infectious diseases
4. Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
5. Subjects who have diagnosed with alcoholism or a history of alcoholism
6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
7. Subjects who have been administered other investigational drug within 12 weeks before the initial administration

8. Subjects who have performed blood collection or donation as follows

   • Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
   • Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
   • Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
   • Collected or donated blood component within 2 weeks before the initial administration
9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
10. Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
11. Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
12. Subjects who cannot speak, read and write in Japanese
13. Subjects who are considered by the investigator as unsuitable for participation in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NPC-12 granule; NPC-12 granules (1.0g: 2mg sirolimus)	Drug: sirolimus; SIngle administration under fasted condition
Active Comparator: NPC-12T tablet; NPC-12T 2 tablets (2mg sirolimus)	Drug: sirolimus; SIngle administration under fasted condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood sirolimus concentration	Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.	Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)

Collaborators and Investigators

• Sponsor: Nobelpharma

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): December 29, 2018
• Study Completion (Actual): December 29, 2018

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: NPC-12T-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No