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
  1. Department of Clinical Research Center, Souseikai Fukuoka Mirai Hospital, Fukuoka, Japan. E-mail: shunji-matsuki@lta-med.com
  2. 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)
  3. Clinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan. E-mail: tetsuya_kouyama@eapharma.co.jp
  4. 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