Trial Outcomes & Findings for A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020) (NCT NCT02411929)
NCT ID: NCT02411929
Last Updated: 2018-09-18
Results Overview
AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.
COMPLETED
PHASE1
8 participants
Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion
2018-09-18
Participant Flow
Participant milestones
| Measure |
Ertugliflozin
Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. The 14\^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. Both the unlabeled and 14\^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
|
|---|---|
|
Period 1
STARTED
|
8
|
|
Period 1
COMPLETED
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
|
Washout Period
STARTED
|
8
|
|
Washout Period
COMPLETED
|
8
|
|
Washout Period
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
8
|
|
Period 2
COMPLETED
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)
Baseline characteristics by cohort
| Measure |
Ertugliflozin
n=8 Participants
Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. The 14\^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. Both the unlabeled and 14\^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
|
|---|---|
|
Age, Continuous
|
41.0 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The pharmacokinetic (PK) Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)
|
93.16 AUCinf(dn), ng•hr/mL/mg
Geometric Coefficient of Variation 13
|
88.96 AUCinf(dn), ng•hr/mL/mg
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
AUC0-last is a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Geometric coefficient of variation is given as the percent coefficient of variation.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)
|
1376 ng•hr/mL
Geometric Coefficient of Variation 12
|
7.859 ng•hr/mL
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the dose. Geometric coefficient of variation is given as the percent coefficient of variation.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
1397 ng•hr/mL
Geometric Coefficient of Variation 13
|
8.477 ng•hr/mL
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Geometric coefficient of variation is given as the percent coefficient of variation.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)
|
17.09 ng/mL/mg
Geometric Coefficient of Variation 14
|
89.34 ng/mL/mg
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. The confidence intervals displayed are minimums to maximums.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Time for Cmax (Tmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
1.00 Hours
Interval 1.0 to 1.5
|
0.083 Hours
Interval 0.083 to 0.1
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
14.04 Hours
Standard Deviation 2.17
|
8.098 Hours
Standard Deviation 2.248
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Apparent clearance is a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14\^C-Ertugliflozin 100 ug IV arm.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Apparent Oral Total Plasma Clearance (CL/F) - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
178.7 mL/min.
Geometric Coefficient of Variation 13
|
—
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Systemic clearance is a calculation of the rate at which a drug is removed from plasma via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Systemic IV Total Plasma Clearance (CL) - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
—
|
187.2 mL/min.
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14\^C-Ertugliflozin 100 ug intravneous arm.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Apparent Volume of Distribution (Vz/F) Following Oral Administration - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
215.3 Liters
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusionPopulation: The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14\^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14\^C parameters of interest.
Steady-State Volume of Distribution is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Steady-State Volume of Distribution (Vss) Following IV Infusion - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
|
—
|
85.53 Liters
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Part 1: pre- IV dose, 0-11 and 11-23 hrs. post IV dose, and 23 - 47, 47 - 71 and 71 - 95 hrs. until Day 5; Part 2: predose, 0-12 and 12-24 hrs. post dose, and then 24-hour intervals until Day 5Population: The estimated Fa Population included only the 6 participants with complete urine data for both treatments.
Fraction absorbed is the fraction of the total ertugliflozin dose absorbed, regardless of the fate of that dose after absorption (i.e., metabolism, degradation, etc). Fraction Absorbed was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time zero to the time of last measurable concentration) following oral and IV administration of 14\^C-ertugliflozin. Fraction of 14\^C dose recovered in urine = 14\^C total in urine in dpm/14\^C total in dose in dpm
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=6 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=6 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Pharmacokinetic Parameter: Fraction Absorbed (Fa, Radioactivity in Urine) (Periods 1 and 2) (Dose Normalized)
|
0.432 Fraction of 14^C dose recovered in urine
Geometric Coefficient of Variation 10
|
0.390 Fraction of 14^C dose recovered in urine
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Up to approximately 33 daysPopulation: The Safety Population included all participants who received at least one dose of study drug.
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (Periods 1 and 2)
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 16 daysPopulation: The Safety Population included all participants who received at least one dose of study drug.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Unlabeled Ertugliflozin 15 mg Oral
n=8 Participants
Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
|
14^C-Ertugliflozin 100 ug IV
n=8 Participants
100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
|
|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to Adverse Events (Periods 1 and 2)
|
0 Participants
|
0 Participants
|
Adverse Events
Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV
Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV
n=8 participants at risk
Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. The 14\^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
|
Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral
n=8 participants at risk
Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. Both the unlabeled and 14\^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • Number of events 1 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
0.00%
0/8 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Up to approximately 33 days
The Safety Population included all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure (poster presentation, invited speaker or guest lecturer presentation) to the sponsor at least 30 days before they are submitted for publication or otherwise disclosed. An additional 60 days will be requested if any patent action is required to protect intellectual property rights. The investigator will, on request, remove any previously undisclosed confidential information before disclosure.
- Publication restrictions are in place
Restriction type: OTHER