Pharmacokinetic study of Eldecalcitol in healthy male volunteers

Phase 1

Completed

• Conditions: Healyhy subjects

• Registration Number: JPRN-jRCT2080223085
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.

Brief Summary

The maximum serum concentration (Cmax) of eldecalcitol was 0.0638 +/- 0.0076 ng/ml in the 0.5 mcg group and 0.0944 +/- 0.0126 ng/ml in the 0.75 mcg group. Area under the concentration-time curve from 0 to 24 h (AUC(0-24h)) was 1.02 +/- 0.15 ng*h/mL in the 0.5 mcg and 1.57 +/- 0.26 ng*h/mL in the 0.75 mcg. The pharmacokinetic parameters were dose-proportional over the tested dose range of 0.5-0.75 mcg in Chinese subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Study Completion: 2016-10-12
• Results First Posted: 2018-08-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

(1) healthy men of age >= 20 and <= 45 at the time of consent and willing to give written informed consent
(2) Those who have BMI within the limits of >= 18.5 and < 25.0 at screening [weight (kg) / height (m)2]

Exclusion Criteria

(1) Those who participated in other clinical studies within four months or six times of half-life of the investigational drug before administration of the study drug of this study, whichever is longer
before the Eldecalcitol starts, and received the Eldecalcitol (including placebo)
(2) Those who have corrected serum Ca within the limits of > 10.4 mg/dL or who have uCa/uCr within the limits of > 0.2.
(3) Those who have abnormalities which need medical treatment by screening.
(4) Those who do not have the will of preventing conception during the start of the investigational drug administration to the end of follow up observation.
(5) In addition, those whom the principal investigator or the subinvestigators judged to be unsuitable as a subject of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified