Trial Outcomes & Findings for Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046) (NCT NCT02549040)
NCT ID: NCT02549040
Last Updated: 2021-01-07
Results Overview
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose
Results posted on
2021-01-07
Participant Flow
Participant milestones
| Measure |
MK-1439 Fixed Sequence Treatment
After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]). During Period 2, participants received Treatment A: MK-1439 100 mg film coated tablet. During Period 3, participants received Treatment C: MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]). During Period 4, participants received Treatment D: MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]. During Period 5, participants received Treatment E: MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]). Each period was separated by a 14 day washout.
|
|---|---|
|
Period 1
STARTED
|
16
|
|
Period 1
COMPLETED
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
16
|
|
Period 2
COMPLETED
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
|
Period 3
STARTED
|
16
|
|
Period 3
COMPLETED
|
16
|
|
Period 3
NOT COMPLETED
|
0
|
|
Period 4
STARTED
|
16
|
|
Period 4
COMPLETED
|
16
|
|
Period 4
NOT COMPLETED
|
0
|
|
Period 5
STARTED
|
16
|
|
Period 5
COMPLETED
|
16
|
|
Period 5
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Baseline characteristics by cohort
| Measure |
MK-1439 Fixed Sequence Treatment
n=16 Participants
After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]). During Period 2, participants received Treatment A: MK-1439 100 mg film coated tablet. During Period 3, participants received Treatment C: MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]). During Period 4, participants received Treatment D: MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]. During Period 5, participants received Treatment E: MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]). Each period was separated by a 14 day washout.
|
|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dosePopulation: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model. Participants were excluded from descriptive statistics for AUC0-inf if there were insufficient data in the terminal phase to characterize half-life (t1/2).
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=13 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=15 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=12 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=15 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439
|
28.6 µM*h
Geometric Coefficient of Variation 34.6
|
31.9 µM*h
Geometric Coefficient of Variation 33.9
|
35.5 µM*h
Geometric Coefficient of Variation 29.6
|
29.1 µM*h
Geometric Coefficient of Variation 30.3
|
28.0 µM*h
Geometric Coefficient of Variation 27.5
|
PRIMARY outcome
Timeframe: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dosePopulation: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439
|
26.3 μM*h
Geometric Coefficient of Variation 29.3
|
29.9 μM*h
Geometric Coefficient of Variation 31.1
|
32.7 μM*h
Geometric Coefficient of Variation 26.3
|
27.0 μM*h
Geometric Coefficient of Variation 28.4
|
26.3 μM*h
Geometric Coefficient of Variation 27.0
|
PRIMARY outcome
Timeframe: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dosePopulation: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439
|
1070 nM
Geometric Coefficient of Variation 26.5
|
1520 nM
Geometric Coefficient of Variation 32.5
|
1320 nM
Geometric Coefficient of Variation 27.8
|
1060 nM
Geometric Coefficient of Variation 27.0
|
1160 nM
Geometric Coefficient of Variation 24.2
|
PRIMARY outcome
Timeframe: Periods 1 to 5: 24 hours post-dosePopulation: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.
During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439
|
395 nM
Geometric Coefficient of Variation 31.9
|
483 nM
Geometric Coefficient of Variation 33.3
|
508 nM
Geometric Coefficient of Variation 23.2
|
412 nM
Geometric Coefficient of Variation 28.0
|
402 nM
Geometric Coefficient of Variation 32.0
|
PRIMARY outcome
Timeframe: Up to 16 days after last dose of study treatment (up to approximately 92 days)Population: All participants who received at least 1 administration of the trial drug.
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
2 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 4 days after last dose of study treatment (up to approximately 76 days)Population: All participants who received at least 1 administration of the trial drug.
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dosePopulation: Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.
During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 hours after dosing to determine AUC0-48hr after a single administration of MK-1439.
Outcome measures
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 Participants
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 Participants
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439
|
22.8 µM*h
Geometric Coefficient of Variation 27.5
|
27.2 µM*h
Geometric Coefficient of Variation 29.2
|
28.8 µM*h
Geometric Coefficient of Variation 24.8
|
23.2 µM*h
Geometric Coefficient of Variation 27.3
|
23.3 µM*h
Geometric Coefficient of Variation 25.9
|
Adverse Events
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment A: MK-1439 100 mg Film Coated Tablet
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment B: MK-1439 150 mg Tablet (40% Drug Loaded Granule)
n=16 participants at risk
Participants received a single MK-1439 Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1
|
Treatment A: MK-1439 100 mg Film Coated Tablet
n=16 participants at risk
Participants received a single MK-1439 100 mg film coated tablet administered orally at the start of Period 2
|
Treatment C: MK-1439 150 mg Tablet (30% Drug Loaded Granule)
n=16 participants at risk
Participants received a single MK-1439 Type 2 dose (150 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 3
|
Treatment D: MK-1439 150 mg Tablet (50% Drug Loaded Granule)
n=16 participants at risk
Participants received a single MK-1439 Type 3 dose (150 mg tablet \[50% drug loaded granule\]) administered orally at the start of Period 4
|
Treatment E: MK-1439 100 mg Tablet (30% Drug Loaded Granule)
n=16 participants at risk
Participants received a single MK-1439 Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5
|
|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
General disorders
Feeling of body temperture change
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
12.5%
2/16 • Number of events 2 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
12.5%
2/16 • Number of events 2 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
12.5%
2/16 • Number of events 2 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
12.5%
2/16 • Number of events 2 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
18.8%
3/16 • Number of events 4 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
12.5%
2/16 • Number of events 2 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Number of events 1 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
0.00%
0/16 • Up to 16 days following the last dose of study treatment (up to approximately 92 days)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER