Trial Outcomes & Findings for MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002) (NCT NCT03552536)

NCT ID: NCT03552536

Last Updated: 2020-03-04

Results Overview

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: Up to Day 29
• Results posted on: 2020-03-04

Participant Flow

Participants with human immunodeficiency virus-1 (HIV-1) infection who were naïve to anti-retroviral therapy (ART) were enrolled. Only participants from Panel A were recruited. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.

Participant milestones

Measure	A: MK-8583 100mg After fasting, a single oral dose of 100 mg MK-8583 in capsule form.	B: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.	C: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
Overall Study STARTED	5	0	0
Overall Study COMPLETED	5	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002)

Baseline characteristics by cohort

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.	B: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.	C: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.	Total n=5 Participants Total of all reporting groups
Age, Continuous	30.2 Years STANDARD_DEVIATION 10.9 • n=5 Participants	—	—	30.2 Years STANDARD_DEVIATION 10.9 • 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	5 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to Day 29

Population: All participants who received at least one dose of treatment. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Number of Participants With at Least One Adverse Event (AE)	4 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All participants who received at least one dose of treatment. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Number of Participants Who Discontinued Study Due to an AE	0 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose) and 168 hours post-dose.

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Plasma HIV-1 RNA was measured at baseline and 168 hours after dosing. Change from baseline for MK-8583 at 168 hours post-baseline was estimated from longitudinal data analysis (LDA) model containing fixed effects for time (predose, 168 hours postdose) and a random effect for participant. The change from baseline in plasma HIV-1 RNA in participants administered MK-8583 was compared with historical placebo data.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at 168 Hours Post-dose.	-0.63 log10 copies/mL Interval -1.3 to 0.05

SECONDARY outcome

Timeframe: Pre-dose, 4, 12, 24, 48, 72, 96, and 168 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of TFV-DP in peripheral blood mononuclear cells (PBMCs) were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-168 hours post-dose (AUC0-168hr) for intracellular TFV-DP is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Area Under the Concentration Time Curve From Time 0-168 Hours Postdose (AUC0-168hr) of Tenofovir Diphosphate (TFV-DP)	324000 hr*nmol/L Geometric Coefficient of Variation 179

SECONDARY outcome

Timeframe: Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of intracellular TFV-DP is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Time to Achieve Maximum Concentration (Tmax) of TFV-DP	12 hr. Interval 4.0 to 12.0

SECONDARY outcome

Timeframe: Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of intracellular TFV-DP is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Maximum Concentration (Cmax) of TFV-DP	4660 nmol/L Geometric Coefficient of Variation 182

SECONDARY outcome

Timeframe: 168 hr postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment. The PBMC sample from one participant was processed incorrectly, so was not included in the analysis. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The concentration at 168 hours postdose (C168hr) of TFV-DP is presented. It is hypothesized that the true geometric mean (GM) of TFV-DP in PBMC is ≥ 0.1 μM (100 nmol/L).

Outcome measures

Measure	A: MK-8583 100mg n=4 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Concentration at 168 Hours Postdose (C168hr) of TFV-DP	940 nmol/L Geometric Coefficient of Variation 414

SECONDARY outcome

Timeframe: Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment. One participant who had insufficient data on terminal phase was not included in the analysis. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent terminal half-life (t1/2) of intracellular TFV-DP is presented.

Outcome measures

Measure	A: MK-8583 100mg n=4 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Apparent Terminal Half-life (t1/2) of TFV-DP	241 hr. Geometric Coefficient of Variation 23.7

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-last measurement (AUC0-last) of plasma MK-8583 is presented. The last quantified concentration value occurred at 2 hours (n=4) and 4 hours (n=1).

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Area Under the Concentration Time Curve From Time 0-last Measurement (AUC0-last) of MK-8583	220 hr*nmol/L Geometric Coefficient of Variation 415

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Due to insufficient plasma concentration data at the terminal phase, AUC0-inf of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of plasma MK-8583 is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Tmax of Plasma MK-8583.	1 hr. Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of plasma MK-8583 is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Cmax of MK-8583	258 nmol/L Geometric Coefficient of Variation 440

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Due to insufficient plasma concentration data at the terminal phase, t1/2 of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Due to insufficient plasma concentration data at the terminal phase, CL/F of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent total clearance (CL/F) of plasma MK-8583 is presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Due to insufficient plasma concentration data at the terminal phase, Vz/F of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-last measurement (AUC0-last) of plasma TFV is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
AUC0-last of Tenofovir (TFV)	1090 hr*nmol/L Geometric Coefficient of Variation 187

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-infinity (AUC0-inf) of plasma TFV is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
AUC0-inf of TFV	1550 hr*nmol/L Geometric Coefficient of Variation 108

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of plasma TFV is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Tmax of TFV	2 hr. Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of plasma TFV is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
Cmax of TFV	64.3 nmol/L Geometric Coefficient of Variation 137

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose

Population: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.

Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent terminal half-life (t1/2) of plasma TFV is presented.

Outcome measures

Measure	A: MK-8583 100mg n=5 Participants After fasting, a single oral dose of 100 mg MK-8583 in capsule form.
t1/2 of TFV	31.5 hr. Geometric Coefficient of Variation 13.2

Adverse Events

MK-8583 100 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

B: MK-8583 ≤ 150 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C: MK-8583 ≤ 150 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MK-8583 100 mg n=5 participants at risk After fasting, a single oral dose of 100 mg MK-8583 in capsule form.	B: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.	C: MK-8583 ≤ 150 mg After fasting, a single oral dose of ≤ 150 mg MK-8583 in capsule form.
Cardiac disorders Sinus tachycardia	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Gastrointestinal disorders Abdominal pain upper	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Infections and infestations Herpes zoster	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Infections and infestations Nasopharyngitis	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Investigations Hepatic enzyme increased	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.
Vascular disorders Haematoma	20.0% 1/5 • Number of events 1 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.	— 0/0 • Up to Day 29 All participants who received at least one dose of treatment. Due to an earlier than anticipated achievement of the study objectives, a decision was made not to conduct Panels B and C.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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