Trial Outcomes & Findings for Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain. (NCT NCT05317312)

NCT ID: NCT05317312

Last Updated: 2023-08-07

Results Overview

Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 111 participants
• Primary outcome timeframe: 24 hours after the first dose
• Results posted on: 2023-08-07

Participant Flow

111 subjects were enrolled / randomized but only 110 subjects were treated.

Participant milestones

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period Oral tablet, one day of dosing Placebo: Placebo oral tablet
Overall Study STARTED	28	28	27	27
Overall Study COMPLETED	28	27	26	26
Overall Study NOT COMPLETED	0	1	1	1

Reasons for withdrawal

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period Oral tablet, one day of dosing Placebo: Placebo oral tablet
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Excluded as exclusion criteria was met.	0	0	1	0

Baseline Characteristics

Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.

Baseline characteristics by cohort

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet	Total n=110 Participants Total of all reporting groups
Age, Continuous	18.9 years STANDARD_DEVIATION 1.45 • n=5 Participants	19 years STANDARD_DEVIATION 1.52 • n=7 Participants	19.3 years STANDARD_DEVIATION 1.94 • n=5 Participants	18.7 years STANDARD_DEVIATION 1.13 • n=4 Participants	19 years STANDARD_DEVIATION 1.53 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	63 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	47 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	23 Participants n=4 Participants	98 Participants n=21 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	0 Participants n=21 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	27 participants n=5 Participants	27 participants n=4 Participants	110 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 hours after the first dose

Population: Modified Intent-to-treat Analysis Set

Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 18 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Overall Summed Pain Intensity Difference (SPID)	74.5 score on a scale x hours Standard Deviation 46.49	82.4 score on a scale x hours Standard Deviation 37.78	96.8 score on a scale x hours Standard Deviation 35.31	50.5 score on a scale x hours Standard Deviation 37.26

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: Modified Intent-to-treat Analysis Set

10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 6-hour windowed last observation carried forward (W6LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 6 hours when calculating SPIDs

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)	2.5 score on a scale Standard Deviation 1.88	3.1 score on a scale Standard Deviation 2.32	2.4 score on a scale Standard Deviation 1.72	3.5 score on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: Modified Intent-to-treat Analysis Set

Measured by double stopwatch technique. The time to onset of first perceptible relief (time that the first watch is stopped) is defined as the postdose time at which the subject first begins to feel pain relief at their estimation.

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=21 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=21 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=26 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=10 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Time to Perceptible Pain Relief.	0.9 hours Interval 0.6 to 3.4	0.7 hours Interval 0.5 to 0.9	0.6 hours Interval 0.4 to 0.7	NA hours Interval 0.8 to Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: Modified Intent-to-treat Analysis Set

Measured by double stopwatch technique The time to meaningful pain relief (time that the second watch is stopped) is defined as the postdose time at which the subject begins to feel meaningful pain relief at their estimation

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=14 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=13 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=21 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=6 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Time to Meaningful Pain Relief	4.5 hours Interval 3.0 to 6.8	5.0 hours Interval 1.5 to Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.	1.5 hours Interval 1.0 to 2.3	3.9 hours Interval 2.9 to Values marked NA (not applicable) have insufficient counts of events to be estimable from the K-M methodology.

SECONDARY outcome

Timeframe: 24 hours

Population: Subjects reporting a PGA score of 2 (good) or better defined as a responder

5 point PGA (Patient's Global Assessment) of pain control scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent

Responder = 2 is good, 3 is very good, and 4 is excellent Non-responder = 1 is fair, 0 is poor, and missing values.

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Patient's Global Assessment of Pain Control	60.7 percentage of PGA responders	67.9 percentage of PGA responders	85.2 percentage of PGA responders	33.3 percentage of PGA responders

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: Rescue Medication Used within 24h

Percentage of subjects using rescue medication from 0-24 hours

Outcome measures

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=28 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 Participants Oral tablet, one day of dosing Placebo: Placebo oral tablet
Rescue Medication Use	42.9 percentage of participants	57.1 percentage of participants	29.6 percentage of participants	74.1 percentage of participants

Adverse Events

MR-107A-02 1.25 mg Twice in a 24 Hour Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MR-107A-02 5 mg Twice in a 24 Hour Period

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

MR-107A-02 15 mg Twice in a 24 Hour Period

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Twice in a 24 Hour Period

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MR-107A-02 1.25 mg Twice in a 24 Hour Period n=28 participants at risk Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 5 mg Twice in a 24 Hour Period n=28 participants at risk Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	MR-107A-02 15 mg Twice in a 24 Hour Period n=27 participants at risk Oral tablet, one day of dosing MR-107A-02: MR-107A-02 oral tablet	Placebo Twice in a 24 Hour Period n=27 participants at risk Oral tablet, one day of dosing Placebo: Placebo oral tablet
Gastrointestinal disorders Nausea	3.6% 1/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	17.9% 5/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Gastrointestinal disorders Vomitting	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	3.7% 1/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Gastrointestinal disorders Diarrhoea	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Investigations Blood bilirubin increased	7.1% 2/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	0.00% 0/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Nervous system disorders Headache	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	3.6% 1/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	11.1% 3/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Nervous system disorders Dizziness	0.00% 0/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	3.6% 1/28 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	7.4% 2/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.	3.7% 1/27 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication. An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.

Additional Information

Susanne Vogt

Viatris

Phone: 004906172

Email: susanne.vogt@viatris.com

Results disclosure agreements

• Principal investigator is a sponsor employee Subject to a multi-site coordination for publication, Institution and Investigator may publish its results by providing a copy of any presentation/publication derived from the Study for review and comment at least 30 days in advance of any disclosure, presentation, or submission for publication in order for the removal of anything that Sponsor identifies as trade secrets, proprietary information or Confidential Information.
• Publication restrictions are in place

Restriction type: OTHER