Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Orion Corporation, Orion Pharma
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent (IC) obtained.
Male aged ≥ 18 years.
Histologically or cytologically confirmed adenocarcinoma of prostate.
Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
Progressive metastatic disease
Adequate bone marrow, hepatic, and renal function
Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
Ability to swallow study treatments
You may not be if
History of pituitary or adrenal dysfunction.
Known brain metastases.
Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
Uncontrolled hypertension
Clinically significant heart disease
Prolonged QTc interval
Clareo Health | Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer
