A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism (NCT07284043) | Clinical Trial Compass
RecruitingPhase 1
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
China6 participantsStarted 2025-11-30
Plain-language summary
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] MT1013.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 1\. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
* 2\. The BMI is between 18 kg/m2 and 35 kg/m2;
* 3\. The subjects must undergo regular maintenance hemodialysis three times a week for at least three monthsï¼›
* 4\. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
* 5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
Exclusion Criteria:
* 1\. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
* 2\. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
* 3\. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
* 4.Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg;
* 5\. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
* 6\. History of malignant tumors within the five years prior to screening;
* 7\. The subjects received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
* 8\. Engaged in work that requires long-term expos…
What they're measuring
1
Cumulative excretion of radioactivity
Timeframe: Day 1 to Day 91.
2
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)