Title page
Type of article: Original article
Evaluation of the potential drug-drug interactions ofcarotegrast methyl with
midazolam, prednisolone, or atorvastatin in healthy adults
Short running title: drug-drug interaction of carotegrast methyl
Shunji
Matsuki1,
Ichiro Oikawa2,
Tetsuya Koyama3, Hiromitsu Imai4
- Department of Clinical Research Center, Souseikai Fukuoka Mirai
Hospital, Fukuoka, Japan. E-mail: shunji-matsuki@lta-med.com
- Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.
(Present address; Department of Clinical Pharmacology and
Therapeutics, Oita University Faculty of medicine, Oita, Japan.
E-mail: oikawaichiro@oita-u.ac.jp)
- Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.
E-mail: tetsuya_kouyama@eapharma.co.jp
- Department of Medical Ethics, Oita University Faculty of Medicine,
Oita, Japan. E-mail: imaih@oita-u.ac.jp
The authors confirmed that the Principal Investigator for this paper is
Shunji Matsuki and that he had direct clinical responsibility for
participants.
Contributor
HI, IO, and SM contributed to the
study design, data interpretation, and were responsible for clinical
trial management. IO performed the analysis of the data. All authors
reviewed the draft and approved the final version of the manuscript for
publication.
Data availability statement:
The study protocol and statistical analysis plan will be shared with
those who request data sharing. Requests for data should be directed to
the corresponding author. Requests will be reviewed, and scientifically
sound proposals will be approved by the sponsor (EA Pharma Co., Ltd. and
Kissei Pharmaceutical Co., Ltd.). In addition, an agreement for data
sharing needs to be contracted between data requestors and the sponsor.
Data will be shared two years after the article publication.
Funding information:
This study was funded by EA Pharma Co., Ltd. (Tokyo, Japan) and Kissei
Pharmaceutical Co., Ltd. (Matsumoto, Japan). EA Pharma Co., Ltd. was
involved in study design, data collection, data analysis, data
interpretation, and writing of the clinical study report. The
corresponding author had full access to all data in the study and had
final responsibility for the decision to submit for publication.
Conflict of interest statement:
IO and TK were employees of EA pharma. SM and HI had no conflicts of
interest to disclose.
Ethics approval statement:
The study protocol and the informed consent form were approved by the
institutional review board of Hakata Clinic. The study was conducted in
accordance with the ethical principles originating in or derived from
the Declaration of Helsinki, and Good Clinical Practice guidelines.
Patient consent statement:
All participants gave written informed consent before initiation of any
study-specific procedures.
Permission to reproduce material from other sources: Not applicable
Clinical trial registration: Japan Registry of Clinical Trials:
jRCT2071230023
Keywords:
AJM300, carotegrast methyl, CYP3A4, drug-drug interaction,
pharmacokinetics
Word count: 3341 (journal limit, 4000)
Abstract: 247 (journal limit, 250)
Table count: 3
Figure count: 2
Corresponding:
Tetsuya Koyama, BSc
EA Pharma Co., Ltd., Clinical Development Department,
2-1-1, Irifune, Chuo-ku, Tokyo, 104-0042. Japan
E-mail:tetsuya_kouyama@eapharma.co.jp
Telephone: +81(0)8037023694