Trial Outcomes & Findings for A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia (NCT NCT03359785)

Last Updated: 2024-02-28

Results Overview

EBC is a method used to investigate cerebellar-dependent learning. In EBC, a conditioned stimulus, a tone precedes but co-terminates with an unconditioned stimulus, an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response) occurs prior to the onset of the unconditioned stimulus. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned). Results are reported as least squares (LS) means at Day 8, determined using an analysis of variance (ANOVA).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Baseline, Day 8 of each treatment period

Results posted on

2024-02-28

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 10 January 2018 to 21 December 2020.

This 2-period cross-over study assessed the pharmacodynamic (PD) effects, safety, tolerability and pharmacokinetics (PK) of multiple oral doses of luvadaxistat given once daily (QD) in adult participants with schizophrenia. Effects of 2 dose levels of luvadaxistat (500 milligrams \[mg\] and 50 mg) or placebo were assessed.

Participant milestones

Participant milestones
Measure	Luvadaxistat 500 mg, Then Placebo Participants first received luvadaxistat 500 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.	Placebo, Then Luvadaxistat 500 mg Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 500 mg orally QD for 8 days during treatment period 2.	Luvadaxistat 50 mg, Then Placebo Participants first received luvadaxistat 50 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.	Placebo, Then Luvadaxistat 50 mg Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 50 mg orally QD for 8 days during treatment period 2.
Overall Study STARTED	8	9	7	7
Overall Study COMPLETED	6	6	5	7
Overall Study NOT COMPLETED	2	3	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Luvadaxistat 500 mg, Then Placebo Participants first received luvadaxistat 500 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.	Placebo, Then Luvadaxistat 500 mg Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 500 mg orally QD for 8 days during treatment period 2.	Luvadaxistat 50 mg, Then Placebo Participants first received luvadaxistat 50 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.
Overall Study Protocol Violation	0	1	0
Overall Study Early study termination due to study pause	0	0	2
Overall Study Withdrawal by Subject	2	2	0

Baseline Characteristics

A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Luvadaxistat 500 mg, Then Placebo n=8 Participants Participants first received luvadaxistat 500 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.	Placebo, Then Luvadaxistat 500 mg n=9 Participants Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 500 mg orally QD for 8 days during treatment period 2.	Luvadaxistat 50 mg, Then Placebo n=7 Participants Participants first received luvadaxistat 50 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2.	Placebo, Then Luvadaxistat 50 mg n=7 Participants Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 50 mg orally QD for 8 days during treatment period 2.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	31 Participants n=21 Participants
Age, Categorical >=65 years	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
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	30 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
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Day 8 of each treatment period

Population: The PD set consisted of all randomized participants who received at least 1 dose of study treatment and had at least 1 post- dose PD result. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=10 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=11 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=11 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in Average Percent of Conditioned Responses During the Eye Blink Conditioning (EBC) Test at Day 8	0.597 Percent of Conditioned Responses Standard Error 0.459	0.319 Percent of Conditioned Responses Standard Error 0.432	0.578 Percent of Conditioned Responses Standard Error 0.444	1.344 Percent of Conditioned Responses Standard Error 0.428

SECONDARY outcome

Timeframe: Baseline, Day 8 of each treatment period

MMN is an event related potential (ERP) evoked in response to unattended changes in background stimulation. MMN reflects an automatic process of detecting a mismatch between a deviant stimulus and a sensory-memory trace. Smaller amplitudes of MMN have been consistently identified in schizophrenia participants. MMN amplitude was measured at midline frontal electrode (Fz) of electroencephalogram (EEG). Baseline was defined as the last observation prior to the dose of study treatment in the corresponding period. Results are reported as LS mean change from baseline at Day 8, determined using an ANOVA.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=13 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=15 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=15 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in the Mean Mismatch Negativity (MMN) at Day 8	-0.239 microvolts Standard Error 0.363	0.669 microvolts Standard Error 0.382	0.594 microvolts Standard Error 0.492	-0.154 microvolts Standard Error 0.501

SECONDARY outcome

Timeframe: Baseline, Day 8 of each treatment period

The P300 wave is an ERP component that is elicited by the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli in a manner similar to MMN but requiring active listening and responding from participants. Auditory stimuli are presented in an oddball paradigm consisting of 1 standard tone and 1 target tone. Participants are instructed to push a button as quickly as possible when they hear the target tone but not when they hear the standard tone. P300 reflects allocation of attention and activation of immediate memory. P300 amplitude was measured at midline parietal electrode (Pz) of EEG. Baseline was defined as the last observation prior to the dose of study treatment in the corresponding period. Results are reported as LS mean change from baseline at Day 8, determined using an ANOVA.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=12 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=14 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=14 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in the Mean P300 Amplitude at Day 8	-2.019 microvolts Standard Error 1.68	0.608 microvolts Standard Error 1.68	1.102 microvolts Standard Error 1.77	2.595 microvolts Standard Error 1.86

SECONDARY outcome

Timeframe: Baseline, Day 8 of each treatment period

ASSRs are evoked oscillatory responses that are entrained to the frequency and phase of temporally modulated stimuli. Individuals with schizophrenia experience subjective sensory anomalies and objective deficits on assessment of sensory function. These deficits can be produced by abnormal signaling in the sensory pathways and sensory cortex or by later-stage disturbances in the cognitive processing of such inputs. ASSR can be used to assess the integrity of sensory pathways including cortical processing. The ASSR applied a frequency stimulus of 40 hertz (Hz) and was measured at midline central electrode (Cz) of EEG. Baseline was defined as the last observation prior to the dose of study treatment in the corresponding period. Results are reported as LS mean change from baseline at Day 8, determined using an ANOVA.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=13 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=15 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=14 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in the Mean Auditory Steady State Response (ASSR) at Day 8	2.135 microvolts-squared Standard Error 8.83	-16.282 microvolts-squared Standard Error 9.31	9.411 microvolts-squared Standard Error 20.4	9.203 microvolts-squared Standard Error 20.9

SECONDARY outcome

Timeframe: Baseline, Day 7 of each treatment period

BACS is a cognition assessment battery and includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory and motor speed. The primary measure from each test is standardized by creating z-scores whereby the mean of the test session of a healthy person is set to 0 and the standard deviation set to 1. A Z-score of 0 represents the population mean. A composite score was calculated by averaging the 4 measures from the BACS used in the study and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participants cognition is compared to a healthy person. Lower z-scores are indicative of lower cognitive performance. Baseline was defined as the last observation prior to the dose of study treatment in the corresponding period. Results are reported as LS mean change from baseline at Day 7, determined using an ANOVA.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=12 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=15 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=15 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score at Day 7	2.574 z-score Standard Error 2.51	5.070 z-score Standard Error 2.55	5.696 z-score Standard Error 1.41	-0.075 z-score Standard Error 1.43

SECONDARY outcome

Timeframe: Day 1 and at multiple time points (up to 6 hours) to Day 8 pre-dose

Population: The PK analysis set included all randomized participants who received at least 1 dose of study treatment and who had any available plasma concentration data. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Blood samples were collected at pre-specified timepoints and plasma concentrations of D-serine and L-serine were measured. Results are reported as LS mean change from baseline at Day 8, determined using a mixed model for repeated measures (MMRM).

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=12 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=15 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=15 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in the Mean Plasma Concentrations of D-serine and L-serine at Day 8 D-serine	0.0402 mg / liter Standard Error 0.00632	-0.000892 mg / liter Standard Error 0.00637	0.0398 mg / liter Standard Error 0.00710	0.00212 mg / liter Standard Error 0.00712
Change From Baseline in the Mean Plasma Concentrations of D-serine and L-serine at Day 8 L-serine	0.669 mg / liter Standard Error 0.479	-0.543 mg / liter Standard Error 0.483	-1.09 mg / liter Standard Error 0.514	-0.304 mg / liter Standard Error 0.516

SECONDARY outcome

Timeframe: Baseline and Day 8 of each treatment period

Blood samples were collected at pre-specified timepoints and plasma concentrations of D-serine and total serine were measured. Plasma D-serine to total serine ratios were then calculated. Results are reported as LS mean change from baseline at Day 8, determined using a MMRM.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=12 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=12 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg n=15 Participants Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) n=15 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Change From Baseline in the Mean Plasma D-serine to Total Serine Ratio at Day 8	0.00293 ratio Standard Error 0.000855	0.000590 ratio Standard Error 0.000863	0.00561 ratio Standard Error 0.000994	0.000620 ratio Standard Error 0.000997

SECONDARY outcome

Timeframe: Day 1 0.25 to 2 hours and 3 to 6 hours post-dose, Day 7 pre-dose, 0.25 to 2 hours and 3 to 6 hours post-dose, and Day 8 pre-dose

Blood samples were collected at pre-specified timepoints and plasma concentrations of luvadaxistat were measured.

Outcome measures

Outcome measures
Measure	Luvadaxistat 50 mg n=14 Participants Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 50 mg) n=15 Participants Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 50 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).	Luvadaxistat 500 mg Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Placebo (Reference for Luvadaxistat 500 mg) Participants received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment in this arm corresponds to participants who received 500 mg luvadaxistat in the alternative treatment period (that is, participants receiving 50 mg and 500 mg luvadaxistat were analyzed separately and placebo treatment was not pooled).
Mean Plasma Concentration of Luvadaxistat Day 1 - Post-dose (0.25 to 2 hours)	253.4 nanograms / milliliter Standard Deviation 199.3	700.4 nanograms / milliliter Standard Deviation 783.0	—	—
Mean Plasma Concentration of Luvadaxistat Day 1 - Post-dose (3 to 6 hours)	47.66 nanograms / milliliter Standard Deviation 35.64	671.1 nanograms / milliliter Standard Deviation 473.1	—	—
Mean Plasma Concentration of Luvadaxistat Day 7 - Pre-dose	8.749 nanograms / milliliter Standard Deviation 19.212	78.92 nanograms / milliliter Standard Deviation 229.90	—	—
Mean Plasma Concentration of Luvadaxistat Day 7 - Post-dose (0.25 to 2 hours)	203.5 nanograms / milliliter Standard Deviation 199.6	1184 nanograms / milliliter Standard Deviation 482	—	—
Mean Plasma Concentration of Luvadaxistat Day 7 - Post-dose (3 to 6 hours)	38.94 nanograms / milliliter Standard Deviation 26.23	301.5 nanograms / milliliter Standard Deviation 177.2	—	—
Mean Plasma Concentration of Luvadaxistat Day 8 - Pre-dose	3.366 nanograms / milliliter Standard Deviation 2.726	21.61 nanograms / milliliter Standard Deviation 14.65	—	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Luvadaxistat 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Luvadaxistat 50 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=29 participants at risk Participants who received matching placebo orally QD for 8 days during either treatment periods 1 or 2 of the study. Placebo treatment was pooled for participants receiving 50 mg and 500 mg luvadaxistat.	Luvadaxistat 500 mg n=15 participants at risk Participants received luvadaxistat 500 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.	Luvadaxistat 50 mg n=14 participants at risk Participants received luvadaxistat 50 mg orally QD for 8 days during either treatment periods 1 or 2 of the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/29 • 8-day treatment period for each of treatment periods 1 and 2 (separated by washout of up to 21 days) and up to 30 days follow-up after last dose of study treatment. Up to a maximum of 67 days for overall timeframe. Treatment-emergent adverse events were defined as adverse events that occurred after the first dose of study treatment and up to 30 days after the last dose or early termination. The safety analysis set included all randomized participants who received at least 1 dose of study treatment.	0.00% 0/15 • 8-day treatment period for each of treatment periods 1 and 2 (separated by washout of up to 21 days) and up to 30 days follow-up after last dose of study treatment. Up to a maximum of 67 days for overall timeframe. Treatment-emergent adverse events were defined as adverse events that occurred after the first dose of study treatment and up to 30 days after the last dose or early termination. The safety analysis set included all randomized participants who received at least 1 dose of study treatment.	7.1% 1/14 • 8-day treatment period for each of treatment periods 1 and 2 (separated by washout of up to 21 days) and up to 30 days follow-up after last dose of study treatment. Up to a maximum of 67 days for overall timeframe. Treatment-emergent adverse events were defined as adverse events that occurred after the first dose of study treatment and up to 30 days after the last dose or early termination. The safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee
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