This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this trial are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Solution for infusion
University Hospital-University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGRigshospitalet
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 161
Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Day 1 up to Day 161
Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Ctrough: Minimum Observed Serum Concentration of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: t½: Apparent Elimination Half-life of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: CL: Apparent Total Serum Clearance of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Parts A and B: Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)
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Copenhagen, Denmark
Chu Angers
Angers, France
RECRUITINGCHU de Lille
Lille, France
RECRUITINGGH Pitié-Salpêtrière
Paris, France
RECRUITINGCHRU Strasbourg
Strasbourg, France
RECRUITINGDavid Metreveli Medical Centre, Tbilisi
Tbilisi, Georgia
RECRUITINGBeaumont Hospital Royal College of Surgeons in Ireland (RCSI), Dublin
Dublin, Ireland
RECRUITINGAzienda Ospedaliero Universitaria di Bologna
Bologna, Italy
RECRUITINGAzienda Ospedaliero-Universitaria Policlinico Umberto I, Roma
Roma, Italy
RECRUITING...and 7 more locations
Time frame: Baseline up to Day 85
Parts A and B: AUC0-tau: Area under the curve over a dosing interval
Time frame: 0 (predose) up to 24 hours postdose on Day 1 to Day 161
Part C: Morning Concentration of A4 in Blood <Upper Limit of Normal (ULN)
Time frame: Day 169
Part C: Lu AG13909 Serum Concentrations Following Multiple IV Doses
Time frame: Baseline up to Day 352
Part C: Change From Baseline of Lu AG13909 in Blood Concentrations of 17-OHP and A4
Time frame: Baseline up to Day 169
Part C: Number of Participants With TEAEs
Time frame: Baseline up to Day 352
Part C: Number of Participants With ADAs
Time frame: Baseline up to Day 352