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Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects

Drug-drug interaction study of TAS-115 with lansoprazole in healthy subjects

14

A total of 14 subjects were enrolled. The mean age of the population was 29.6 years, and all subjects were healthy male Japanese.

Enrolled: 14 Treated: 14 Completed: 14 Not Completed: 0

Analysis Population: All-Treated Population 14 subjects Treatment-emergent adverse events (TEAEs) were reported in 5 subjects (35.7%). No treatment-related adverse events (TRAEs) and serious TEAEs were reported. Three subjects (21.4%) experienced diarrhoea in each period (TAS-115 alone period, lansoprazole alone period and combined period); overall, diarrhoea occurred in four subjects (28.6%). Eczema impetiginous and pain in extremity occurred in one subject each (7.1%) in the lansoprazole alone period and TAS-115 alone period. Maximum grade of the TEAEs s was Grade 2 (eczema impetiginous), and other TEAEs s were Grade 1.

Primary outcome measures (Analysis Population: PK-Evaluable Population 14 patients) The adverse events are described in the 'Adverse events' section. Coadministration of TAS-115 with lansoprazole decreased the Cmax, AUClast, and AUCinf of TAS-115 by approximately 31%, 25%, and 25%, respectively, relative to TAS-115 alone. Secondary outcome measures (Analysis Population: All Treated Population 14 subjects) The adverse events are described in the 'Adverse events' section. No clinically significant changes or abnormalities were observed in 12-lead ECGs and laboratory data.

It was confirmed that coadministration of TAS-115 with lansoprazole decreased the Cmax and AUC of TAS-115 by approximately 31% and 25%, respectively, in this study. There were no safety concerns for the combination of TAS-115 and acid-reducing agents; however, clinically relevant impact of combination use of acid-reducing agents on the efficacy of TAS-115 should be evaluated in consideration of the results of the exposure-response relationship of TAS-115 in future clinical studies for patients.

No

Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.

https://jrct.mhlw.go.jp/latest-detail/jRCT2071210016

Huang Jinhong

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

ta-honda@taiho.co.jp

Honda Takayuki

Taiho Pharmaceutical Co., Ltd

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2113

ta-honda@taiho.co.jp

Complete

July. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Provided written informed consent
(2) Men aged 20 or older and younger than 40 years at the time of consent
(3) Weigh at least 50.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height (m)]2) ranging from 18.5 to < 25.0 kg/m2
(4) Vital signs obtained in screening tests within the following ranges
a) Systolic blood pressure (in supine position), 90 to 139 mmHg
b) Diastolic blood pressure (in supine position), 40 to 89 mmHg
c) Pulse rate ranging from 40 to 99 beats/min
d) Body temperature (axilla) ranging from 35.0 to 37.0
(5) Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests

(1) Accompanying diseases considered inappropriate for participation in this study including hepatic diseases, renal diseases, gastrointestinal diseases, cardiovascular diseases, hematologic diseases, respiratory diseases, immunologic or allergic diseases, neurological or psychiatric diseases, metabolic or endocrinological diseases, or malignant tumors, or a history of these diseases

Male

Idiopathic pulmonary fibrosis

Day 1:TAS-115 will be orally administered.
Day11-Day14:Lansoprazole will be orally administered once a day.
Day 15:Lansoprazole will be orally administered and TAS-115 will be orally administered 1 hour later.

PK parameters of TAS-115(Cmax, AUClast, and AUCinf)

- Incidence of adverse events and treatment-related adverse events
- Changes in laboratory test values
- Electrocardiogram

+81-92-283-7701

June. 18, 2021

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