Background: Risedronate is a potent inhibitor of osteoclast-mediated bone resorption. Absorption of risedronate is known to decrease remarkably after meals. Therefore, the conventional immediate-release (IR) tablet must be taken at least 30 min before the first meal of the day, and the patient should refrain from lying down for at least 30 min after taking the IR tablet. NE-58095 DR is a novel risedronate delayed-release (DR) tablet under development to improve absorption and patient adherence. The objective of this study was to perform an exploratory assessment of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the DR tablet by dose or food effect.

Methods: In the ascending dose stage, the NE-58095 DR dose was sequentially escalated from 25 mg to 75 mg in order to compare it with the conventional 75-mg IR tablet. In the subsequent food effect stage, the effect of food intake on the PK, PD, and safety profiles was investigated at the DR dose that is comparable to the conventional 75-mg IR tablet. The DR tablets were administered immediately after a meal, 30 min before a meal, 30 min after a meal, or under fasting conditions. All subjects were healthy postmenopausal Japanese women.

Results: PK analysis showed that 25- and 37.5-mg DR doses were comparable to the conventional 75-mg IR tablet. Although administration of the 37.5-mg DR tablet under fasting conditions demonstrated the highest exposure and administration immediately after a meal resulted in the lowest exposure, food had no major impact on the PD parameters investigated.

Conclusions: The 25- and 37.5-mg DR tablets exhibited PK profiles comparable to those of the 75-mg IR tablet. There was no influence of meals on the PD parameters of 37.5-mg DR tablet in this clinical trial.

Background: Participants in clinical studies in Japan may receive less support than participants in Chiken (clinical trials for marketing approval). In the Five Year Activation Plan for Clinical Study/Trial 2012, the government requested medical institutions to consider a consultation service for all clinical study participants, in addition to the existing consultation services provided by Chiken. The service was firstly intended to be created at 15 model institutions. The plan, however, did not specify any requirements for the service.

Objective: To investigate how the consultation service is currently being provided and utilized at institutions throughout Japan in support of clinical study participants, and to consider how to better support and protect research participants.

Methods: In 2016, we conducted a questionnaire survey of 15 model institutions designated in the Action Plan for the Five Year Plan. We additionally interviewed individuals in charge of the consultation services at those institutions to obtain in-depth information.

Results: Ten institutions responded to the survey. Nine of them had established the service. Four institutions provided us with detailed responses through interviews and e-mail. The majority of consultations reported were inquiries for research participation addressed by ill patients and their relatives, instead of questions or concerns made by actual clinical study participants.

Limitations: Since most of the institutions that responded to the survey already had consultation services prior to our survey, the situation at the institutions that did not respond to the survey is still unclear.

Conclusions: The majority of consultation services are currently being used to provide information to patients and their family members regarding research participation, rather than as consultations for study participants. The primary role of the consultation service as a protection for research participants needs to be reconsidered.