Trial Outcomes & Findings for Oral LAT8881 in Neuropathic Pain (NCT NCT03865953)

NCT ID: NCT03865953

Last Updated: 2021-06-14

Results Overview

The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain. The efficacy of oral LAT8881 in neuropathic pain was compared with placebo, when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: Baseline to Week 4
• Results posted on: 2021-06-14

Participant Flow

Participant milestones

Measure	LAT8881, Then Placebo In the first intervention period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, a placebo capsule was taken twice daily (morning and evening) for four weeks.	Placebo, Then LAT8881 In the first intervention period, a placebo capsule was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks.
First Intervention (4 Weeks) STARTED	25	28
First Intervention (4 Weeks) COMPLETED	23	27
First Intervention (4 Weeks) NOT COMPLETED	2	1
Washout/Baseline Period (3 Weeks) STARTED	23	27
Washout/Baseline Period (3 Weeks) COMPLETED	23	27
Washout/Baseline Period (3 Weeks) NOT COMPLETED	0	0
Second Intervention (4 Weeks) STARTED	23	27
Second Intervention (4 Weeks) COMPLETED	23	25
Second Intervention (4 Weeks) NOT COMPLETED	0	2

Reasons for withdrawal

Measure	LAT8881, Then Placebo In the first intervention period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, a placebo capsule was taken twice daily (morning and evening) for four weeks.	Placebo, Then LAT8881 In the first intervention period, a placebo capsule was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks.
First Intervention (4 Weeks) Lost to Follow-up	2	0
First Intervention (4 Weeks) Protocol Violation	0	1
Second Intervention (4 Weeks) Lost to Follow-up	0	2

Baseline Characteristics

Oral LAT8881 in Neuropathic Pain

Baseline characteristics by cohort

Measure	LAT8881, Then Placebo n=25 Participants In the first intervention period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, a placebo capsule was taken twice daily (morning and evening) for four weeks.	Placebo, Then LAT8881 n=28 Participants In the first intervention period, a placebo capsule was taken twice daily (morning and evening) for four weeks. After a 3 week washout/baseline non-treatment period, 1 x 30 mg capsule of LAT8881 was taken twice daily (morning and evening) for four weeks.	Total n=53 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 11.33 • n=5 Participants	58.5 years STANDARD_DEVIATION 8.91 • n=7 Participants	59.8 years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	21 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Australia	19 participants n=5 Participants	22 participants n=7 Participants	41 participants n=5 Participants
Neuropathic pain history Post herpetic neuralgia (PHN)	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Neuropathic pain history Diabetic peripheral neuropathy (DPN)	17 Participants n=5 Participants	26 Participants n=7 Participants	43 Participants n=5 Participants
PainDETECT questionnaire (PD-Q) scores	21.0 units on a scale STANDARD_DEVIATION 3.62 • n=5 Participants	20.9 units on a scale STANDARD_DEVIATION 5.03 • n=7 Participants	20.9 units on a scale STANDARD_DEVIATION 4.38 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: The per protocol population was used for all efficacy analyses. This population excluded subjects with inadequate exposure to treatment or who had other major protocol deviations.

The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain.

The efficacy of oral LAT8881 in neuropathic pain was compared with placebo, when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS)	-0.87 score on a scale Standard Deviation 1.53	-0.74 score on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo

Population: Pharmacokinetic subset of the per protocol population

To investigate the effect of oral LAT8881 in neuropathic pain compared with placebo, as measured by the numeric pain rating score (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain.

This outcome was investigated only in the pharmacokinetic subset of per protocol subjects.

Outcome measures

Measure	LAT8881 n=14 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=14 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Absolute baseline score, first dose	4.5 score on a scale Standard Deviation 2.2	4.8 score on a scale Standard Deviation 1.9
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 0.5 hours after first dose	-0.1 score on a scale Standard Deviation 0.77	-0.2 score on a scale Standard Deviation 1.53
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 1 hour after first dose	-0.4 score on a scale Standard Deviation 0.63	-0.6 score on a scale Standard Deviation 1.95
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 2 hours after first dose	-0.1 score on a scale Standard Deviation 0.95	-0.8 score on a scale Standard Deviation 2.26
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 4 hours after first dose	0.1 score on a scale Standard Deviation 1.07	-0.6 score on a scale Standard Deviation 2.17
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 6 hours after first dose	0.0 score on a scale Standard Deviation 0.68	-0.7 score on a scale Standard Deviation 1.77
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Absolute baseline score, last dosing day	4.4 score on a scale Standard Deviation 2.2	4.0 score on a scale Standard Deviation 2.2
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 0.5 hours after last dose	-0.6 score on a scale Standard Deviation 2.43	-0.4 score on a scale Standard Deviation 0.84
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 1 hour after last dose	-0.5 score on a scale Standard Deviation 2.58	-0.4 score on a scale Standard Deviation 1.02
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 2 hours after last dose	-0.8 score on a scale Standard Deviation 2.19	-0.1 score on a scale Standard Deviation 0.77
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 4 hours after last dose	-0.5 score on a scale Standard Deviation 2.26	-0.4 score on a scale Standard Deviation 0.93
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo Change from baseline, 6 hours after last dose	-0.7 score on a scale Standard Deviation 1.93	-0.4 score on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: 1,2 and 3 weeks

Population: Per protocol population

To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS Baseline	6.18 units on a scale Standard Deviation 1.53	6.18 units on a scale Standard Deviation 1.45
Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS Change from baseline at Week 1	-0.50 units on a scale Standard Deviation 1.37	-0.55 units on a scale Standard Deviation 1.27
Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS Change from baseline at Week 2	-0.73 units on a scale Standard Deviation 1.49	-0.91 units on a scale Standard Deviation 1.62
Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS Change from baseline at Week 3	-0.84 units on a scale Standard Deviation 1.61	-0.84 units on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population

To determine the proportion of subjects with at least a 30% reduction in mean NPRS after 4 weeks treatment. The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A decrease in pain score represents an improvement in pain.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population

To determine the proportion of subjects with at least a 50% reduction in mean the numeric pain rating scale (NPRS) after 4 weeks treatment. The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A decrease in pain score represents an improvement in pain.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 1,2,3 or 4 weeks

Population: Per protocol population

To determine the maximum effects of oral LAT8881 in neuropathic pain, compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain..

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Maximum Change in Mean NPRS	-1.53 score on a scale Standard Deviation 1.37	-1.55 score on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population.

To evaluate the effects of oral LAT8881, compared with placebo, on functioning when measured by the Brief Pain Inventory Interference Scale (BPI). The BPI assesses the severity of pain and its impact on functioning. Patients are asked to assess the level of interference experienced across seven items; general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with a "0" meaning "no interference, and a "10", at the top end of the scale, meaning "complete interference". The result is the mean of the score of the seven items. A reduction in mean score indicates a decrease in interference.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI) Baseline BPI	4.71 score on a scale Standard Deviation 2.45	4.91 score on a scale Standard Deviation 2.32
Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI) Change from baseline	-0.57 score on a scale Standard Deviation 1.83	-1.12 score on a scale Standard Deviation 1.97

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population.

To evaluate the effect of oral LAT8881, compared with placebo, on pain symptoms in subjects with neuropathic pain, when measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2). The SF-MPQ-2 contains 22 descriptors of pain and related symptoms, each scored from "0" (none) to "10" (worst possible). The scores for each descriptor at each visit are averaged to give a mean score from 0 to 10. A larger negative number represents a greater reduction in pain.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2) Baseline SF-MPQ-2	3.88 score on a scale Standard Deviation 1.81	3.86 score on a scale Standard Deviation 1.73
Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2) Change from baseline	-0.66 score on a scale Standard Deviation 1.34	-0.63 score on a scale Standard Deviation 1.70

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population.

The Neuropathic Pain Symptom Inventory (NPSI) contains ten items related to different pain descriptors (e.g. burning, squeezing, electric-shock, stabbing, tingling), allowing the assessment of the different dimensions of neuropathic pain, and two items related to the frequency and duration of pain. Each pain descriptor is rated on an 11-point numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Total pain intensity score is calculated by the sum of the 10 descriptors and can range from 0 to 100. A higher score indicates a higher pain intensity. A larger negative number represents a greater reduction in pain.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI) Baseline NPSI	40.7 score on a scale Standard Deviation 17.2	41.1 score on a scale Standard Deviation 16.2
Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI) Change from baseline	-6.0 score on a scale Standard Deviation 14.5	-7.4 score on a scale Standard Deviation 16.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population.

To evaluate the effect of oral LAT8881, compared with placebo, on emotional functioning when measured by the Beck Depression Inventory-II (BDI-II). The BDI-II consists of 21 items; each item is a list of four statements arranged in order of increasing severity about a particular symptom of depression. Each statement is scored from 0 to 3. Each of the 21 items is summed to give a single score for the BDI-II. Scores can range from 0 (no depression) to 63 (severe depression). An increase from baseline to the end of treatment indicates a deterioration.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II Baseline BDI-II	11.3 score on a scale Standard Deviation 8.6	12.1 score on a scale Standard Deviation 9.3
Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II Change from baseline	-1.1 score on a scale Standard Deviation 4.14	-1.2 score on a scale Standard Deviation 7.98

SECONDARY outcome

Timeframe: 4 weeks

Population: Per protocol population

The Patient Global Impression of Change (PGIC) is a a single-item rating by subjects of their improvement with treatment during a clinical trial. It asks the subject to rate their improvement with therapy on a 7-point scale, ranging from substantially worse ("0") to substantially improved ("7"), with no change ("4") as the mid-point. A score above 4 indicates an improvement.

Outcome measures

Measure	LAT8881 n=50 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=50 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Patient Global Impression of Change Score	4.5 score on a scale Standard Deviation 1.23	4.8 score on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Weekly over four-week treatment

Population: Full analysis set

To determine the change from baseline in paracetamol rescue medication use during oral LAT8881 administration, compared with placebo.

Outcome measures

Measure	LAT8881 n=53 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=53 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Rescue Medication Use Week 1	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.
Rescue Medication Use Week 2	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.
Rescue Medication Use Week 3	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.
Rescue Medication Use Week 4	NA gram Standard Deviation NA Only one subject took additional paracetamol rescue medication (1 g/day on three days only). Due to this limited use of rescue medication, it was not considered appropriate to calculate rescue medication use per week for the group compared with baseline.	NA gram Standard Deviation NA No subjects took additional paracetamol rescue medication, compared with baseline.

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Subgroup of the pharmacokinetic population

Cmax is calculated after the first dose of IMP on Day 1 and after 4 weeks treatment on the morning of Day 28

Outcome measures

Measure	LAT8881 n=3 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=3 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881 Cmax, Day 1	NA ng/mL Standard Deviation NA Cmax could not be calculated as the majority of samples were below the limit of quantification.	NA ng/mL Standard Deviation NA Cmax could not be calculated as the majority of samples were below the limit of quantification.
Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881 Cmax, Day 28	NA ng/mL Standard Deviation NA Cmax could not be calculated as the majority of samples were below the limit of quantification.	NA ng/mL Standard Deviation NA Cmax could not be calculated as the majority of samples were below the limit of quantification.

SECONDARY outcome

Timeframe: Day 1 and day 28

Population: subgroup of the pharmacokinetic population

Tmax after the first dose of investigational medicinal product (IMP) and after 4 weeks treatment with IMP

Outcome measures

Measure	LAT8881 n=3 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=3 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Time to Maximum Plasma Concentration of LAT8881 (Tmax) Tmax, Day 1	NA hours Standard Deviation NA Tmax could not be calculated as the majority of samples were below the limit of quantification.	NA hours Standard Deviation NA Tmax could not be calculated as the majority of samples were below the limit of quantification.
Time to Maximum Plasma Concentration of LAT8881 (Tmax) Tmax, Day 28	NA hours Standard Deviation NA Tmax could not be calculated as the majority of samples were below the limit of quantification.	NA hours Standard Deviation NA Tmax could not be calculated as the majority of samples were below the limit of quantification.

SECONDARY outcome

Timeframe: Day 1 and Day 28

Population: Subgroup of the pharmacokinetic population

AUC0-inf after the first dose of IMP and after 4 weeks of treatment

Outcome measures

Measure	LAT8881 n=3 Participants 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=3 Participants 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) AUC0-inf, Day 1	NA ng-hr/mL Standard Deviation NA AUC0-inf could not be calculated as the majority of samples were below the limit of quantification.	NA ng-hr/mL Standard Deviation NA AUC0-inf could not be calculated as the majority of samples were below the limit of quantification.
Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) AUC0-inf, Day 28	NA ng-hr/mL Standard Deviation NA AUC0-inf could not be calculated as the majority of samples were below the limit of quantification.	NA ng-hr/mL Standard Deviation NA AUC0-inf could not be calculated as the majority of samples were below the limit of quantification.

Adverse Events

LAT8881

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LAT8881 n=51 participants at risk 1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule	Placebo n=51 participants at risk 1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule
Infections and infestations Upper respiratory tract infection	5.9% 3/51 • Number of events 4 • Adverse events were collected from the first dose of study treatment until the End of Study visit, maximum 93 days	5.9% 3/51 • Number of events 3 • Adverse events were collected from the first dose of study treatment until the End of Study visit, maximum 93 days
Nervous system disorders Headache	3.9% 2/51 • Number of events 3 • Adverse events were collected from the first dose of study treatment until the End of Study visit, maximum 93 days	7.8% 4/51 • Number of events 4 • Adverse events were collected from the first dose of study treatment until the End of Study visit, maximum 93 days

Additional Information

Mr David Kenley

Lateral Pharma Pty Ltd

Phone: +61 (0)400 151 490

Email: dk@lateral-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Except for legal reasons, the investigator will not reveal the result of the study to a third party without a mutual agreement about the analysis and interpretation of the data with the sponsor.
• Publication restrictions are in place

Restriction type: OTHER