Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227, United States
NCT Number: NCT04663464
A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women
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Notify Me40 year–65 year
All sexes
Interventional
Phase 1
Cincinnati, Ohio, 45227, United States
This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Other names: BA058; abaloparatide-sMTS
Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
Other names: BA058; abaloparatide-SC
Time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Maximum observed concentration (Cmax)
Time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Time frame: Time frame for collection of PK data after each single-dose administration, separated by 48 hours
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Time frame: 10 Days
Subjects with treatment-emergent AEs and SAEs.
Radius Health, Inc.
Industry
An Open-Label, Randomized, 2-Cohort, 2-Period Crossover Pharmacokinetic Study of Abaloparatide-SC and Abaloparatide-sMTS in Healthy Men and Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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