Trial Outcomes & Findings for Study to Evaluate SPI-1005 in Adults With Meniere's Disease (NCT NCT02603081)

NCT ID: NCT02603081

Last Updated: 2026-06-29

Results Overview

Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

7 weeks

Results posted on

2026-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	High Dose 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	9	10	10	9
Overall Study NOT COMPLETED	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	High Dose 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Non-compliance with protocol	1	0	0	0

Baseline Characteristics

Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	High Dose n=10 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Total n=40 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 9.88 • n=10 Participants	50.9 years STANDARD_DEVIATION 9.75 • n=10 Participants	48.7 years STANDARD_DEVIATION 9.30 • n=10 Participants	56.3 years STANDARD_DEVIATION 9.27 • n=10 Participants	52.6 years STANDARD_DEVIATION 9.66 • n=40 Participants
Sex: Female, Male Female	5 Participants n=10 Participants	6 Participants n=10 Participants	5 Participants n=10 Participants	4 Participants n=10 Participants	20 Participants n=40 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	4 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=10 Participants	20 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=10 Participants	39 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=40 Participants
Race (NIH/OMB) White	10 Participants n=10 Participants	7 Participants n=10 Participants	10 Participants n=10 Participants	9 Participants n=10 Participants	36 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=40 Participants
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	10 participants n=10 Participants	10 participants n=10 Participants	40 participants n=40 Participants
Plasma Selenium level	162.0000 ng/mL STANDARD_DEVIATION 55.30145 • n=9 Participants • Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.	138.5714 ng/mL STANDARD_DEVIATION 16.91013 • n=7 Participants • Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.	153.6000 ng/mL STANDARD_DEVIATION 18.06900 • n=10 Participants • Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.	157.5556 ng/mL STANDARD_DEVIATION 25.94760 • n=9 Participants • Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.	153.7714 ng/mL STANDARD_DEVIATION 32.9269 • n=35 Participants • Selenium values of \>800 ng/mL are excluded from the analysis. Selenium values of \>800 ng/mL were categorized but specific measurements were not obtained.

PRIMARY outcome

Timeframe: 7 weeks

Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=10 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Incidence of of Treatment-Emergent Adverse Events	5 Participants	4 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 21 days

Population: Blood samples taken from participants assigned to the placebo group were not analyzed since no ebselen was administered.

Trough values

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=8 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing Ebselen	77.209 ng/mL Standard Deviation 1.5030	—	16.766 ng/mL Standard Deviation 1.4675	67.232 ng/mL Standard Deviation 1.4578
Plasma Ebselen Levels of SPI-1005 After 21 Days of Dosing Ebselen Glucuronide (major metabolite)	506.266 ng/mL Standard Deviation 3.1807	—	102.058 ng/mL Standard Deviation 2.5087	505.977 ng/mL Standard Deviation 3.2061

SECONDARY outcome

Timeframe: 7 weeks

Plasma selenium levels at 28 days post-treatment

Outcome measures

Outcome measures
Measure	High Dose n=8 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=9 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=9 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=9 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Plasma Selenium Levels	201.7500 ng/mL Standard Deviation 37.96145	139.5556 ng/mL Standard Deviation 23.17925	171.7778 ng/mL Standard Deviation 32.11611	187.3333 ng/mL Standard Deviation 45.73292

SECONDARY outcome

Timeframe: 7 weeks

Number of participants demonstrating improvement in Sensorineural Hearing Loss measured using pure tone audiometry. Improvement was defined as a decrease from baseline value by 10 dB or more at one or more low-frequency thresholds (0.25, 0.5, or 1.0 kHz) in at least one ear.

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=9 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Impact on Sensorineural Hearing Loss	4 Participants	3 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 7 weeks

Number of participants demonstrating improvement in Speech Discrimination measured using the Words in Noise test. Improvement was defined as an increase from baseline value by 10% or more in the total score (0-35, where a higher score is a better outcome) in at least one ear.

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=9 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Impact on Speech Discrimination	3 Participants	4 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 7 weeks

Number of participants demonstrating improvement in the Tinnitus Functional Index (TFI). Improvement was defined as a decrease from baseline value by 10 points or more in the total score (0-100, where a higher score is a worse outcome).

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=9 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Impact on Tinnitus	3 Participants	5 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 7 weeks

Number of participants demonstrating improvement in the Vertigo Symptom Scale - Short Form (VSS). Improvement was defined as a decrease from baseline value by 6 points or more in the total score (0-60, where a higher score is a worse outcome).

Outcome measures

Outcome measures
Measure	High Dose n=9 Participants 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Placebo n=9 Participants 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 Participants 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 Participants 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Impact on Vertigo	3 Participants	7 Participants	5 Participants	4 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Low Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Mid Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

High Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Sound Pharmaceuticals, Inc.

Phone: 2066342559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=10 participants at risk 0 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Low Dose n=10 participants at risk 200 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	Mid Dose n=10 participants at risk 400 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.	High Dose n=9 participants at risk 600 mg SPI-1005 bid po x 21d SPI-1005: Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Ear and labyrinth disorders Ear pain	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Eye disorders Dry eye	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Gastrointestinal disorders Abdominal pain lower	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Gastrointestinal disorders Constipation	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Gastrointestinal disorders Flatulence	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Gastrointestinal disorders Nausea	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Infections and infestations Kidney infection	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Infections and infestations Ophthalmic herpes simplex	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Psychiatric disorders Nervousness	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Infections and infestations Pharyngitis	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Injury, poisoning and procedural complications Arthropod bite	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Investigations Alanine aminotransferase increased	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	20.0% 2/10 • Number of events 2 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	33.3% 3/9 • Number of events 3 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Investigations Aspartate aminotransferase increased	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Investigations Blood cholesterol increased	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	20.0% 2/10 • Number of events 2 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Investigations Blood lactate dehydrogenase increased	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	20.0% 2/10 • Number of events 2 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Investigations Blood urea increased	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	20.0% 2/10 • Number of events 2 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Nervous system disorders Headache	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Psychiatric disorders Insomnia	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	10.0% 1/10 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/9 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	0.00% 0/10 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).	11.1% 1/9 • Number of events 1 • 7 weeks Only treatment emergent adverse events are included, i.e., adverse events which occurred after the first dose of study drug treatment (active or placebo).