(22382) A combined single- and multiple-dose, open-label, fixed sequence, 2 x 3 crossover study to investigate the relative bioavailability, safety and tolerability of elinzanetant (BAY 3427080) in healthy female and male participants.
interventional
N/A
1 country
1
Investigate the relative bioavailability of elinzanetant after single fasted dosing of formulation A versus formulation B and formulation A versus formulation C.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2023
Actual (reported)AUC (or AUC(0-tlast), if AUC cannot be determined in all subjects) after single dose under fasted condition (formulation A, B, C)
Cmax after single dose under fasted condition (formulation A, B, C)
Cmax,md (Day 13) and Cmax,md (Day 14) after multiple oral dosing 3 h after light dinner (formulation A)
AUC(0-24)md after multiple oral dosing 3 h after light dinner (formulation A)
Ctrough,d14 and Ctrough,d15 after multiple oral dosing 3 h after light dinner (formulation A)
Cmax,md after multiple oral dosing 3 h after light dinner (formulation B and C)
AUC(0-24)md after multiple oral dosing 3 h after light dinner (formulation B and C)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BAY 3427080
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordFormulated product
BAY 3427080
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BAY 3427080
Named ingredient: elinzanetant
View registry recordBAY 3427080
Named ingredient: elinzanetant
View registry recordNuvisan GmbH
Neu-Ulm, 89231, Germany
Therapeutic Area Head
First Submitted
May 16, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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