Status:
COMPLETED
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Amolyt Pharma
Conditions:
Chronic Hypoparathyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of AZP-3601 following single and repeated administration in both healthy volunteers and patients with chroni...
Eligibility Criteria
Inclusion
- Main inclusion criteria
- Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2
- Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2
- Part C:
- Male and female patients aged 18 to 75 years inclusive
- History of cHP for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (PTH).
- Requirement for therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day (both are active vitamin D supplements), and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above normal dietary calcium intake at baseline assessments.
- Main exclusion criteria
- Parts A and B:
- Clinically significant abnormal lab values, as judged by the investigator
- Using tobacco products with 3 months prior to first drug administration
- History of alcohol abuse or drug addiction
- Part C:
- Known history of autosomal-dominant hypocalcemia (ADH resulting from gain-of-function calcium-sensing receptor \[CaSR\] or GNA11 mutations) or pseudohypoparathyroidism (impaired responsiveness to PTH)
- Any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than HP
- Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides (e.g., digoxin or digitoxin) or systemic corticosteroids within 4 weeks prior to start of treatment.
- Previous treatment with PTH-like drugs, including PTH(1-84), PTH(1-34), or abaloparatide, within 3 months prior to screening.
Exclusion
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05239221
Start Date
September 7 2020
End Date
August 23 2022
Last Update
September 8 2025
Active Locations (2)
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1
Amolyt Pharma Investigational Site Hungary
Budapest, Hungary
2
PRA-EDS
Groningen, Netherlands, 9728