Trial Outcomes & Findings for A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005) (NCT NCT01466985)
NCT ID: NCT01466985
Last Updated: 2019-02-15
Results Overview
The change from baseline to Day 7 in plasma HIV RNA viral load was determined for each arm. Results are expressed as change in HIV RNA log10 copies/mL after 7 daily doses of doravirine or placebo. It was hypothesized that at least 1 dose of doravirine would be superior to placebo as documented by the upper bound of the 90% confidence interval \<-1. Plasma HIV RNA levels were determined using the Abbott RealTime HIV assay which has a linear range from 40 to 10 million copies/mL.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Baseline and Day 7
Results posted on
2019-02-15
Participant Flow
Participants with human immunodeficiency virus type 1 (HIV-1) who were antiretroviral therapy (ART)-naïve were enrolled at a single study center in Germany.
Participants were allocated into panels, then randomized to doravirine 25 mg or placebo (Panel A) or doravirine 200 mg or placebo (Panel B). The protocol planned for a possible Panel C but Panel C was not enrolled. Study results are presented according to actual treatment received.
Participant milestones
| Measure |
Doravirine 25 mg
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)
Baseline characteristics by cohort
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
n=6 Participants
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.7 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
34.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
26.8 Years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
32.8 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 7Population: All participants who received ≥1 dose of study drug are included (results are presented according to actual treatment received).
The change from baseline to Day 7 in plasma HIV RNA viral load was determined for each arm. Results are expressed as change in HIV RNA log10 copies/mL after 7 daily doses of doravirine or placebo. It was hypothesized that at least 1 dose of doravirine would be superior to placebo as documented by the upper bound of the 90% confidence interval \<-1. Plasma HIV RNA levels were determined using the Abbott RealTime HIV assay which has a linear range from 40 to 10 million copies/mL.
Outcome measures
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
n=6 Participants
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Percentage Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
|
-1.52 Percentage change
Interval -1.71 to -1.32
|
-1.41 Percentage change
Interval -1.61 to -1.21
|
-0.15 Percentage change
Interval -0.35 to 0.06
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7Population: All participants who received ≥1 dose of doravirine are included.
The AUC0-24hr of doravirine on Day 7 was determined in the doravirine treatment arms.
Outcome measures
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of Doravirine on Day 7
|
11.2 uM*hr
Interval 9.35 to 13.4
|
62.2 uM*hr
Interval 52.0 to 74.4
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7Population: All participants who received ≥1 dose of doravirine are included.
The Cmax of doravirine on Day 7 was determined in the doravirine treatment arms.
Outcome measures
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Doravirine on Day 7
|
826 nM
Interval 727.0 to 938.0
|
4300 nM
Interval 3790.0 to 4890.0
|
—
|
SECONDARY outcome
Timeframe: 24 hours postdose on Day 7 (Day 8)Population: All participants who received ≥1 dose of doravirine are included.
The C24hr of doravirine on Day 7 was determined in the doravirine treatment arms.
Outcome measures
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Plasma Concentration 24 Hours Postdose (C24hr) of Doravirine on Day 7
|
251 nM
Interval 188.0 to 335.0
|
1540 nM
Interval 1150.0 to 2060.0
|
—
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7Population: All participants who received ≥1 dose of doravirine are included.
The Tmax of doravirine on Day 7 was determined in the doravirine treatment arms.
Outcome measures
| Measure |
Doravirine 25 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 Participants
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Doravirine on Day 7
|
1.00 Hours
Interval 1.0 to 2.0
|
2.00 Hours
Interval 1.0 to 4.0
|
—
|
Adverse Events
Doravirine 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Doravirine 200 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Poststudy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doravirine 25 mg
n=6 participants at risk
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 participants at risk
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
n=6 participants at risk
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
Poststudy
n=18 participants at risk
AEs from all participants in the study were pooled for the poststudy period.
|
|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
5.6%
1/18 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
Other adverse events
| Measure |
Doravirine 25 mg
n=6 participants at risk
Participants with HIV-1 infection received doravirine 25 mg q.d. for 7 days.
|
Doravirine 200 mg
n=6 participants at risk
Participants with HIV-1 infection received doravirine 200 mg q.d. for 7 days.
|
Placebo
n=6 participants at risk
Participants with HIV-1 infection received placebo q.d. by mouth for 7 days.
|
Poststudy
n=18 participants at risk
AEs from all participants in the study were pooled for the poststudy period.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
33.3%
2/6 • Number of events 3 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
5.6%
1/18 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 2 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
16.7%
1/6 • Number of events 1 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
33.3%
2/6 • Number of events 3 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
33.3%
2/6 • Number of events 3 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
0.00%
0/18 • Up to 14 days after the last dose of study drug (up to 21 days)
All participants who received ≥1 dose of study therapy are included. Adverse event d are summarized by study treatment received for the 7-day treatment period and are pooled for the 14-day poststudy period.
|
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 study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER