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

• ClinicalTrials.gov Identifier: NCT03765944
• Recruitment Status: Completed
• First Posted: December 5, 2018
• Last Update Posted: February 25, 2019
• Sponsor: Nobelpharma
• Information provided by (Responsible Party): Nobelpharma

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bioequivalence Study	Drug: sirolimus	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults
• Actual Study Start Date: December 5, 2018
• Actual Primary Completion Date: December 29, 2018
• Actual Study Completion Date: December 29, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 39 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Japan

Clinique Soigner

Matsudo, Chiba, Japan, 270 -2231

Sponsors and Collaborators

Nobelpharma

More Information

• Responsible Party: Nobelpharma
• ClinicalTrials.gov Identifier: NCT03765944
• Other Study ID Numbers: NPC-12T-1
• First Posted: December 5, 2018
• Last Update Posted: February 25, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sirolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs