NCT03286829
Study to Investigate the Pharmacokinetic Profile
See it on ClinicalTrials.gov ↗60 people
100%
0 womenmiddle line = equal numbers60 men
- Phase
- PHASE1
- Paid for by
- Saniona
- Finished
- 2018-02-06
- Health conditions
- Healthy Male Subjects
- Who could join
- Men only
- Ages
- 18 Years – 55 Years
- Average age
- median 40.7 years
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 98.3% · Asian 1.7% · American Indian / Alaska Native 0% · Native Hawaiian / Pacific Islander 0% · Black / African American 0% · More than one race 0% · Not reported 0%
Women left out
- Men only
No women were allowed to join.
“Eligibility: Male participants only.”
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 55 Years.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“BMI between 18.5 and 30.0 kg/m2, inclusive, at the Screening Visit.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…icant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.”
- No cancer
Women with current or past cancer were turned away.
“…icant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.”
Study titles and rules are shown in their original English.