A Phase II, multi-site, open-label, dose-titration trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of Lu AG13909 in adults with Cushing’s disease

Conditions

Cushing's Disease

Brief summary

Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period [ Time Frame: Up to 490 days ], Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 1023 days ], PK endpoint: Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909 [ Time Frame: Up to 659 days ], PK endpoint: Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough [ Time Frame: Up to 659 days ], PK endpoint: AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State [ Time Frame: Up to 1037 days ], PK endpoint: CL: Systemic Clearance of Lu AG13909 [ Time Frame: Up to 1037 days ], PK endpoint: t½: Elimination Half-life of Lu AG13909 [ Time Frame: Up to 1037 days ], PK endpoint: Vd: Apparent Volume of Distribution of Lu AG13909 [ Time Frame: Up to 1037 days ], PK endpoint: SC Bioavailability (F) of Lu AG13909 [ Time Frame: Up to 1037 days ]

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period [ Time Frame: Up to 490 days ], Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 1023 days ], PK endpoint: Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909 [ Time Frame: Up to 659 days ], PK endpoint: Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough [ Time Frame: Up to 659 days ], PK endpoint: AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State [ Time Frame: Up to 1037 days ], PK endpoint: CL: Systemic Clearance of Lu AG13909 [ Time Frame: Up to 1037 days ], PK endpoin	—

Measure

Time frame

Part A & Part B: Urinary Free Cortisol (UFC) Complete Response: mean UFC (mUFC) ≤ Upper Limit of Normal (ULN) at the end of the IV/SC Titration Period [ Time Frame: Up to 490 days ], Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 1023 days ], PK endpoint: Part A Only: Cmax: Maximum Observed Plasma Concentration of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A Only: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Lu AG13909 [ Time Frame: Up to 323 days ], PK endpoint: Part A & Part B: Ctrough: Minimum Observed Concentration of Lu AG13909 [ Time Frame: Up to 659 days ], PK endpoint: Part A & Part B: Ttrough: Nominal Time Corresponding to the Occurrence of Ctrough [ Time Frame: Up to 659 days ], PK endpoint: AUC0-tau,ss: Area Under the Plasma Concentration Curve of Lu AG13909 at Steady State [ Time Frame: Up to 1037 days ], PK endpoint: CL: Systemic Clearance of Lu AG13909 [ Time Frame: Up to 1037 days ], PK endpoin

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Countries

France, Hungary, Italy, Poland, Romania, Spain

Outcome results