How radiolabeled MT1013 is processed and cleared in people on hemodialysis with secondary hyperparathyroidism

A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

We will test how a radiolabeled MT1013 is distributed and removed from the body in adults on regular hemodialysis who have secondary hyperparathyroidism.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07284043 on ClinicalTrials.gov

What this trial studies

This Phase 1 mass-balance study gives a single dose of [14C] MT1013 to adults on maintenance hemodialysis and measures total radioactivity in blood, urine, feces, and dialysis effluent over time to determine routes and extent of excretion. Serial blood sampling and collection of excreta will quantify absorption, distribution, metabolism, and elimination of the radiolabeled drug. Safety monitoring and coordination with routine dialysis sessions will be performed during and after dosing. The data will inform dosing, safety, and design of future clinical studies in this patient population.

Who should consider this trial

Good fit: Adults aged 18 or older who are male or postmenopausal female with confirmed secondary hyperparathyroidism, BMI 18–35 kg/m2, serum calcium ≥8.4 mg/dL, and on thrice-weekly maintenance hemodialysis for at least three months who can provide informed consent.

Not a fit: Patients planning parathyroidectomy or ablation, those with recent gastrointestinal bleeding, recent myocardial infarction or coronary intervention, severe uncontrolled hypertension, or who do not meet the dialysis or demographic criteria are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could show how MT1013 is cleared in dialysis patients and help establish safer dosing and monitoring guidelines for future use.

How similar studies have performed: Mass-balance studies using radiolabeled compounds are a standard pharmacokinetic approach that have successfully defined excretion pathways for many drugs, although MT1013 itself is a novel agent.

Eligibility criteria

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 months；
* 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 exposure to radioactive conditions; Or those who have had significant radioactive exposure or participated in radioactive drug labeling tests within one year prior to screening;
* 9\. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.

Where this trial is running

Jinan, Shandong

• The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Wei Zhao, Ph.D.

Conditions: Hemodialysis Subjects With Secondary Hyperparathyroidism