Trial Outcomes & Findings for Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363) (NCT NCT00688467)

NCT ID: NCT00688467

Last Updated: 2019-01-02

Results Overview

This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change \>0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline and between 3 and 7 hours after allergen challenge
• Results posted on: 2019-01-02

Participant Flow

Participant milestones

Measure	Navarixin → Placebo Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2	Placebo → Navarixin Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Treatment Period 1 STARTED	9	10
Treatment Period 1 COMPLETED	7	8
Treatment Period 1 NOT COMPLETED	2	2
Treatment Period 2 STARTED	7	8
Treatment Period 2 COMPLETED	7	6
Treatment Period 2 NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Navarixin → Placebo Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2	Placebo → Navarixin Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Treatment Period 1 Adverse Event	2	1
Treatment Period 1 Did not meet protocol eligibility	0	1
Treatment Period 2 Protocol Violation	0	1
Treatment Period 2 Adverse Event	0	1

Baseline Characteristics

Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)

Baseline characteristics by cohort

Measure	Navarixin → Placebo n=9 Participants Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2	Placebo → Navarixin n=10 Participants Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2	Total n=19 Participants Total of all reporting groups
Age, Continuous	34.3 Years STANDARD_DEVIATION 12.0 • n=5 Participants	24.9 Years STANDARD_DEVIATION 4.0 • n=7 Participants	29.4 Years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and between 3 and 7 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods

This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin	35.427 Percent change from baseline Standard Deviation 27.377 • Interval -17.726 to 92.784	26.225 Percent change from baseline Standard Deviation 27.377 • Interval -16.977 to 94.929

SECONDARY outcome

Timeframe: Baseline and between 3 and 7 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods

Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin	0.571 Liters Standard Deviation 0.306	0.438 Liters Standard Deviation 0.306

SECONDARY outcome

Timeframe: Baseline and 24 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods

This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge	-0.161 Log methacholine (mg/mL) Standard Deviation 0.205	-0.154 Log methacholine (mg/mL) Standard Deviation 0.205

SECONDARY outcome

Timeframe: Baseline and between 0 to 2 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods

This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin	35.325 Percent change from baseline Standard Deviation 16.261	35.924 Percent change from baseline Standard Deviation 16.261

SECONDARY outcome

Timeframe: Baseline and between 0 to 2 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods

Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin	32.251 Percent change from baseline Standard Deviation 7.398	30.872 Percent change from baseline Standard Deviation 7.398

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples

Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.

Outcome measures

Measure	Placebo n=5 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=4 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin 7 hours after allergen challenge (n=3, n=4)	-8.189 Percent change from baseline Standard Deviation 31.188	-45.043 Percent change from baseline Standard Deviation 31.188
Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin 24 hours after allergen challenge (n=4, n=5)	7.057 Percent change from baseline Standard Deviation 10.302	-40.412 Percent change from baseline Standard Deviation 10.302

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods and had evaluable blood samples available

Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.

Outcome measures

Measure	Placebo n=13 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=13 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin 7 hours after allergen challenge (n=11, n=12)	-0.029 Percent change from baseline Standard Deviation 0.106	-0.066 Percent change from baseline Standard Deviation 0.106
Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin 24 hours after allergen challenge (n=13, n=13)	0.078 Percent change from baseline Standard Deviation 0.089	0.034 Percent change from baseline Standard Deviation 0.089

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples

Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.

Outcome measures

Measure	Placebo n=6 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=6 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin 7 hours after allergen challenge (n=6, n=4)	18136.2 pg/mL Standard Deviation 7167.68	-1746.5 pg/mL Standard Deviation 7167.68
Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin 24 hours after allergen challenge (n=6, n=6)	13195.2 pg/mL Standard Deviation 8149.08	-856.66 pg/mL Standard Deviation 8149.08

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples

Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.

Outcome measures

Measure	Placebo n=6 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=6 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin 7 hours after allergen challenge (n=6, n=4)	230.416 mU/mL Standard Deviation 380.316	-254.92 mU/mL Standard Deviation 380.316
Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin 24 hours after allergen challenge (n=6, n=6)	2.264 mU/mL Standard Deviation 303.402	-166.27 mU/mL Standard Deviation 303.402

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: MPO level was not analyzed because too few evaluable samples were collected

Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 7 and 24 hours after allergen challenge

Population: ECP level was not analyzed because too few evaluable samples were collected

Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 48 days

Population: The population analyzed included all participants who received study drug

An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.

Outcome measures

Measure	Placebo n=17 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=16 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Number of Participants With an Adverse Event (AE)	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 48 days

Population: The population analyzed included all participants who received study drug

An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.

Outcome measures

Measure	Placebo n=17 Participants Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Navarixin n=16 Participants Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Number of Participants Discontinued From the Study Because of an Adverse Event	1 Participants	3 Participants

Adverse Events

Navarixin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Navarixin n=16 participants at risk Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Placebo n=17 participants at risk Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Infections and infestations Gastroenteritis	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.

Other adverse events

Measure	Navarixin n=16 participants at risk Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days	Placebo n=17 participants at risk Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
Blood and lymphatic system disorders Lymphadenopathy	6.2% 1/16 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Blood and lymphatic system disorders Neutropenia	25.0% 4/16 • Number of events 4 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	0.00% 0/17 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Nervous system disorders Headache	12.5% 2/16 • Number of events 3 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Nervous system disorders Migraine	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 3 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Psychiatric disorders Insomnia	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Reproductive system and breast disorders Menstruation delayed	6.2% 1/16 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	0.00% 0/17 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 2/16 • Number of events 2 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	0.00% 0/17 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Skin and subcutaneous tissue disorders Dermatitis contact	6.2% 1/16 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	0.00% 0/17 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	5.9% 1/17 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.
Infections and infestations Gastroenteritis	6.2% 1/16 • Number of events 1 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.	0.00% 0/17 • Up to 48 days (the day of the last dose of study drug in Treatment Period 2) Adverse events were collected for all participants who received \>=1 dose of study drug in either treatment period. Adverse events were reported based on the study drug taken at the time of the event.

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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
• Publication restrictions are in place

Restriction type: OTHER