Trial Outcomes & Findings for A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004) (NCT NCT02461563)

NCT ID: NCT02461563

Last Updated: 2018-11-13

Results Overview

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product 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), 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: 12 participants
• Primary outcome timeframe: Up to Day 42
• Results posted on: 2018-11-13

Participant Flow

Males or females of non-child bearing potential with verified Genotype 1 (GT1) or Genotype 3 (GT3) Hepatitis C Virus (HCV) infection, between the ages of 18 and 65 years (inclusive) were enrolled in this trial.

GT1 and GT3 participants planned to receive 200 mg MK-1075 were not treated based on available data from previous studies.

Participant milestones

Measure	GT1 400 mg MK-1075 Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	3	3	3	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

Baseline characteristics by cohort

Measure	GT1 400 mg MK-1075 n=3 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=3 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	Total n=12 Participants Total of all reporting groups
Age, Continuous	39.3 Years STANDARD_DEVIATION 9.3 • n=5 Participants	39.7 Years STANDARD_DEVIATION 11.0 • n=7 Participants	39.0 Years STANDARD_DEVIATION 3.0 • n=5 Participants	46.0 Years STANDARD_DEVIATION 7.0 • n=4 Participants	41.0 Years STANDARD_DEVIATION 7.6 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 42

Population: Participants who received at least one dose of the investigational drug.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product 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), 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	GT1 400 mg MK-1075 n=3 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=3 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Number of Participants Who Experienced an Adverse Event (AE)	3 Participants	2 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to Day 7

Population: Participants who received at least one dose of the investigational drug.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product 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), 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	GT1 400 mg MK-1075 n=3 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=3 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Number of Participants Who Discontinued Treatment Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 (pre-dose, 2, 4, 8, 12, and 24 hours postdose); Days 3, 4, 5, 6 (pre-dose); Day 7 (predose, 4, 12, 24, 48, 72, 96, 120, and 192 hours postdose); Days 21, 28 and 42

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. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

Blood was collected on Days 1, 3, 4, 5, 6, 7, 21, 28 and 42, where baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. Change from baseline in log10 HCV RNA levels, was determined, and the maximum reduction in HCV RNA was analyzed by an ANOVA model with a fixed effect for treatment. The primary hypothesis is, with a posterior probability larger than 70%, there is at least a 3 log10 reduction from baseline in HCV RNA.

Outcome measures

Measure	GT1 400 mg MK-1075 n=3 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=3 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 n=3 Participants Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Change From Baseline in Maximum log10 HCV RNA Following Multiple Dose Oral Administration of MK-1075	3.465 log10 IU/mL Interval 2.427 to 4.502	4.122 log10 IU/mL Interval 3.084 to 5.159	4.071 log10 IU/mL Interval 3.034 to 5.109	5.132 log10 IU/mL Interval 4.095 to 6.169

SECONDARY outcome

Timeframe: Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose

Population: AUC 0-24hr were not determined because concentrations of MK-1075 at 24 hour were not quantifiable

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 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. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of the MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.

Outcome measures

Measure	GT1 400 mg MK-1075 n=6 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=6 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
AUC 0-24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075	35.3 hr*μmol/L Geometric Coefficient of Variation 12.9	51.2 hr*μmol/L Geometric Coefficient of Variation 12	—	—

SECONDARY outcome

Timeframe: Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120 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. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.

Outcome measures

Measure	GT1 400 mg MK-1075 n=6 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=6 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Area Under the Plasma Concentration Time Curve From Time 0 to Last (AUC 0-last) of MK-1075 Following Multiple Dose Oral Administration of MK-1075	1.1 hr*μmol/L Geometric Coefficient of Variation 41.3	0.89 hr*μmol/L Geometric Coefficient of Variation 54.2	—	—

SECONDARY outcome

Timeframe: Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120 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. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.

Outcome measures

Measure	GT1 400 mg MK-1075 n=6 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=6 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
AUC 0-last of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075	62.2 hr*μmol/L Geometric Coefficient of Variation 29.6	90.6 hr*μmol/L Geometric Coefficient of Variation 20.9	—	—

SECONDARY outcome

Timeframe: Day 7 at 24 hours postdose

Population: C24hr were not determined because concentrations of MK-1075 at 24 hour were not quantifiable.

Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK- 1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7 at 24 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. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).

Outcome measures

Measure	GT1 400 mg MK-1075 n=6 Participants Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 MK-1075 600 mg n=6 Participants Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 400 mg MK-1075 Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 600 mg MK-1075 Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
C24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075	0.561 μmol/L Geometric Coefficient of Variation 39.9	0.947 μmol/L Geometric Coefficient of Variation 25.8	—	—

Adverse Events

GT1 Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GT3 Pre-treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

GT1 400 mg MK-1075

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GT1 600 mg MK-1075

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

GT3 MK-1075 400 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GT3 600 mg MK-1075

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

GT1 Post-study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

GT3 Post-study

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	GT1 Pre-treatment n=6 participants at risk GT1 participants were enrolled for 4 weeks prior to randomization and treatment.	GT3 Pre-treatment n=6 participants at risk GT3 participants were enrolled for 4 weeks prior to randomization and treatment.	GT1 400 mg MK-1075 n=3 participants at risk Fasted GT1 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT1 600 mg MK-1075 n=3 participants at risk Fasted GT1 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days	GT3 MK-1075 400 mg n=3 participants at risk Fasted GT3 participants were administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days.	GT3 600 mg MK-1075 n=3 participants at risk Fasted GT3 participants were administered 600 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days.	GT1 Post-study n=6 participants at risk After treatment Day 7, GT1 participants were monitored for AEs up to Day 42.	GT3 Post-study n=6 participants at risk After treatment Day 7, GT3 participants were monitored for AEs up to Day 42.
Investigations White blood cells urine positive	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Nervous system disorders Dizziness	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Nervous system disorders Headache	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	66.7% 2/3 • Number of events 2 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	66.7% 2/3 • Number of events 3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Nervous system disorders Tension headache	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	66.7% 2/3 • Number of events 2 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Gastrointestinal disorders Nausea	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
General disorders Fatigue	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	100.0% 3/3 • Number of events 3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.
General disorders Feeling hot	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/3 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	33.3% 1/3 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	0.00% 0/6 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.	16.7% 1/6 • Number of events 1 • Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42 Participants who received at least one dose of the investigational drug. Adverse events are also reported for GT1 and GT3 arms during Pre-treatment and Post-study periods.

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