Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17 With Oral Curcumin in Normal Men With Experimental Hypogonadism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OralT12
Brief Summary:
This study will be performed in normal men whose endogenous testosterone production has been temporarily suppressed by the administration of a single dose of 120 mg of the oral GnRH antagonist Relugolix which is approved for the treatment of prostate cancer and can suppress endogenous testosterone biosynthesis for 48-72 hours after a single dose
Detailed Description:
The study will have three phases a screening period a 3-day drug exposure period and a one-month recovery period see Table 1 Experimental Design
Screening Visit At screening study investigators will consent subjects perform an interview and physical examination blood samples for measurement of hormones T
DHT Estradiol E2 FSH and LH routine hematology chemistry and hepatic function and a DNA sample for UGT2B17 genotype will be obtained from the buccal mucosa and a spot urine specimen obtained for a testosterone glucuronideandrosterone glucuronide ratio a marker of endogenous UGT2B17 activity No drugs will be administered in the screening period The screening visit should take approximately 60 minutes
Day 1 15-minute visit Blood pressure and heart rate will be measured prior to the administration of Relugolix 120 mg orally on an empty stomach
Day 2 9 hour stay Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two ensures The first dose of oral testosterone will be administered at 0900 - 30 minutes in the morning with two Ensures After drug administration subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose 05 1 15 2 3 4 6 and 8 hours after the morning dose and will have the iv removed
Day 3 9 hour stay Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two Ensures and 630 mg of oral Curcumin The second dose of oral testosterone will be administered at 0900 - 30 minutes in the morning After drug administration subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose 05 1 15 2 3 4 6 and 8 hours after the morning dose and will have the iv removed
Day 4 15-minute visit Subjects will come into the clinic at 0900 for a 24-hour blood draw and adverse effect assessment
Day 28-42 30-minute visit Subjects will undergo a final assessment physical examination vitals and weight measurements and blood draw on day 28-42 We will confirm at the follow-up visit that there has been recovery from Relugolix-induced hypogonadism ie testosterone levels have returned to within 25 of baseline If a subject has not recovered by this visit he will be reassessed at 2-week intervals until recovery is documented The total amount of blood drawn over the study protocol will not exceed 500 mL per subject
Screening Visit At screening study investigators will consent subjects perform an interview and physical examination blood samples for measurement of hormones T
DHT Estradiol E2 FSH and LH routine hematology chemistry and hepatic function and a DNA sample for UGT2B17 genotype will be obtained from the buccal mucosa and a spot urine specimen obtained for a testosterone glucuronideandrosterone glucuronide ratio a marker of endogenous UGT2B17 activity No drugs will be administered in the screening period The screening visit should take approximately 60 minutes
Day 1 15-minute visit Blood pressure and heart rate will be measured prior to the administration of Relugolix 120 mg orally on an empty stomach
Day 2 9 hour stay Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two ensures The first dose of oral testosterone will be administered at 0900 - 30 minutes in the morning with two Ensures After drug administration subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose 05 1 15 2 3 4 6 and 8 hours after the morning dose and will have the iv removed
Day 3 9 hour stay Placement of IV and dosing of Testosterone Undecanoate 237 mg once with two Ensures and 630 mg of oral Curcumin The second dose of oral testosterone will be administered at 0900 - 30 minutes in the morning After drug administration subjects will have 10 ccs of blood drawn for the measurement of serum testosterone for the measurement of testosterone Predose 05 1 15 2 3 4 6 and 8 hours after the morning dose and will have the iv removed
Day 4 15-minute visit Subjects will come into the clinic at 0900 for a 24-hour blood draw and adverse effect assessment
Day 28-42 30-minute visit Subjects will undergo a final assessment physical examination vitals and weight measurements and blood draw on day 28-42 We will confirm at the follow-up visit that there has been recovery from Relugolix-induced hypogonadism ie testosterone levels have returned to within 25 of baseline If a subject has not recovered by this visit he will be reassessed at 2-week intervals until recovery is documented The total amount of blood drawn over the study protocol will not exceed 500 mL per subject
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None