Trial Outcomes & Findings for Safety and Pharmacokinetics of VT-1598 (NCT NCT04208321)

NCT ID: NCT04208321

Last Updated: 2024-07-26

Results Overview

Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, pulse \<= 54 bpm (baseline \> 60 bpm) or \<=50 (baseline \<= 60 bpm) or \>= 101 bpm, respiratory rate \>= 17 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline (Day -1) through Day 21
• Results posted on: 2024-07-26

Participant Flow

Participants included healthy adult male and female subjects aged 18-45 (inclusive). Participants were recruited from the local community to ensure that male, female, and minorities (African American, Native American, Asian, and Hispanics) were represented in the enrolled population. Participants were enrolled between 29SEP2020 and 17NOV2021.

Participant milestones

Measure	40 mg Fasted 40 mg (1 tablet of 40 mg) of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	80 mg Fasted 80 mg (2 tablets of 40 mg) of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	160 mg Fasted 160 mg (4 tablets of 40 mg) of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	160 mg Fed 160 mg (4 tablets of 40 mg) of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	320 mg Fasted 320 mg (4 tablets of 80 mg) of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	640 mg Fasted 640 mg (8 tablets of 80 mg) of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. VT-1598: VT-1598 is a novel oral agent for the treatment of fungal infections. It is supplied as 40 mg and 80 mg tablets.	Placebo Placebo participants across all cohorts: 40 mg (1 tablet of 40 mg) while fasting on Day 1; 80 mg (2 tablets of 40 mg) while fasting on Day 1; 160 mg (4 tablets of 40 mg) while fasting on Day 1; 160 mg (4 tablets of 40 mg) after a high-calorie, high-fat meal on Day 1; 320 mg (4 tablets of 80 mg) while fasting on Day 1; or 640 mg (8 tablets of 80 mg) while fasting on Day 1 of matching placebo administered orally as a single dose in a double-blind manner. Placebo: Placebo is supplied in matching tablets (to 40 mg and 80 mg VT-1598 tablets) containing the inactive components of VT-1598.
Overall Study STARTED	6	6	6	6	6	6	12
Overall Study COMPLETED	6	6	6	6	6	6	12
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetics of VT-1598

Baseline characteristics by cohort

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.	Total n=48 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 6.4 • n=5 Participants	33.8 years STANDARD_DEVIATION 5.2 • n=7 Participants	34.5 years STANDARD_DEVIATION 2.4 • n=5 Participants	39.5 years STANDARD_DEVIATION 3.4 • n=4 Participants	38.3 years STANDARD_DEVIATION 8.9 • n=21 Participants	38.3 years STANDARD_DEVIATION 6.3 • n=10 Participants	33.3 years STANDARD_DEVIATION 6.1 • n=115 Participants	35.5 years STANDARD_DEVIATION 6.1 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	20 Participants n=24 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	8 Participants n=115 Participants	28 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	6 Participants n=115 Participants	27 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants	19 Participants n=24 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	1 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	15 Participants n=24 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	8 Participants n=115 Participants	33 Participants n=24 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Height	163.23 cm STANDARD_DEVIATION 5.51 • n=5 Participants	169.62 cm STANDARD_DEVIATION 11.32 • n=7 Participants	163.63 cm STANDARD_DEVIATION 8.47 • n=5 Participants	170.75 cm STANDARD_DEVIATION 13.51 • n=4 Participants	166.05 cm STANDARD_DEVIATION 14.13 • n=21 Participants	168.33 cm STANDARD_DEVIATION 11.65 • n=10 Participants	174.16 cm STANDARD_DEVIATION 12.14 • n=115 Participants	168.74 cm STANDARD_DEVIATION 11.42 • n=24 Participants
Weight	70.28 kg STANDARD_DEVIATION 15.26 • n=5 Participants	90.08 kg STANDARD_DEVIATION 21.19 • n=7 Participants	72.70 kg STANDARD_DEVIATION 6.88 • n=5 Participants	77.77 kg STANDARD_DEVIATION 16.98 • n=4 Participants	80.32 kg STANDARD_DEVIATION 18.76 • n=21 Participants	84.42 kg STANDARD_DEVIATION 12.74 • n=10 Participants	88.41 kg STANDARD_DEVIATION 14.76 • n=115 Participants	81.55 kg STANDARD_DEVIATION 16.26 • n=24 Participants
Body Mass Index (BMI)	26.17 kg/m^2 STANDARD_DEVIATION 4.23 • n=5 Participants	30.83 kg/m^2 STANDARD_DEVIATION 4.16 • n=7 Participants	27.18 kg/m^2 STANDARD_DEVIATION 2.38 • n=5 Participants	26.47 kg/m^2 STANDARD_DEVIATION 3.09 • n=4 Participants	28.95 kg/m^2 STANDARD_DEVIATION 4.28 • n=21 Participants	30.05 kg/m^2 STANDARD_DEVIATION 5.11 • n=10 Participants	29.07 kg/m^2 STANDARD_DEVIATION 3.10 • n=115 Participants	28.47 kg/m^2 STANDARD_DEVIATION 3.86 • n=24 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 21

Population: Safety Population: All participants that received any amount of study product.

Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Unsolicited Adverse Events Nervous system disorders	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events General disorders and administration site conditions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Unsolicited Adverse Events Musculoskeletal and connective tissue disorders	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events Infections and infestations	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Unsolicited Adverse Events Injury, poisoning and procedural complications	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Unsolicited Adverse Events Investigations	6 Participants	6 Participants	6 Participants	5 Participants	3 Participants	5 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) through Day 21

Population: Safety Population: All participants that received any amount of study product.

Laboratory parameters and associated thresholds include albumin <=3.4 g/dL, glucose <= 69 mg/dL or >=106 mg/dL, blood urea nitrogen (BUN) >= 21 mg/dL, potassium >=5.2 mEq/L or <=3.4 mEq/L, calcium < 8.7 mg/dL or >=10.3 mg/dL, sodium <=132 mEq/L or >=144 mEq/L, total protein <=5.9 g/dL, creatinine >=1.3 mg/dL (male) or >= 1.0 mg/dL (female), creatine phosphokinase >= 308 U/L (male) or >=192 U/L (female), phosphorus <=2.4 mg/dL, alkaline phosphatase >= 130 IU/L (males) or >= 105 IU/L (female), aspartate aminotransferase >= 39.9 U/L (male) or >= 31.9 U/L (female), alanine aminotransferase >=40.9 U/L (male) or >= 32.9 U/L (female), total bilirubin >=1.2 mg/dL, direct bilirubin >=0.2 mg/dL, magnesium <=1.6 mg/dL, and serum cortisol <= 4 ug/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Albumin, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Calcium, Decrease	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Calcium, Increase	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Sodium, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Sodium, Increase	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Total Protein, Decrease	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Creatinine, Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Creatine Phosphokinase, Increase	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Phosphorus, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Alkaline Phosphatase, Increase	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Aspartate Aminotransferase, Increase	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Alanine Aminotransferase, Increase	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Total Bilirubin, Increase	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Direct Bilirubin, Increase	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Magnesium, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Serum Cortisol, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Glucose, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Glucose, Increase	4 Participants	2 Participants	3 Participants	3 Participants	1 Participants	3 Participants	4 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Blood Urea Nitrogen, Increase	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Potassium, Decrease	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results Potassium, Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) through Day 21

Population: Safety Population: All participants that received any amount of study product.

Laboratory parameters and associated thresholds for adverse events include hemoglobin <= 12.2 g/dL (male) or <= 10.8 g/dL (female), hematocrit <= 36.1 % (male) or <= 32.6 % (female), lymphocyte count <= 799 cell/mm3, neutrophil count <= 1,299 cell/mm3 (African Americans) or <= 1,699 cell/mm3 (all others), monocyte count >= 1001 cell/mm3, eosinophil count >= 871 cell/mm3, basophil count >= 101 cell/mm3, platelet count <= 150 x 10^3/mm3, red blood cell (RBC) count <= 4.1 x 10^6/uL (male) or <= 3.7 x 10^6/uL (female), and white blood cell (WBC) count >= 9,001 cell/mm3 or <= 2,499 cell/mm3 (African American Males) or >= 11,001 cell/mm3 or <= 2,499 cell/mm3 (African American Females) or >= 10,001 cell/mm3 or <= 3,999 cell/mm3 (all others). If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Hemoglobin, Decrease	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Hematocrit, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Lymphocytes, Decrease	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Neutrophils, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Monocytes, Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Eosinophils, Increase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Basophils, Increase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Platelets, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results Red Blood Cell, Decrease	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results White Blood Cell, Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Hematology Laboratory Toxicity Results White Blood Cell, Increase	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) through Day 21

Population: Safety Population: All participants that received any amount of study product.

Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT >= 11.6 s, PTT >= 30.1 s, INR >= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results Activated Partial Thromboplastin Time, Increase	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results Prothrombin Time, Increase	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results Prothrombin International Normalized Ratio, Increase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) through Day 21

Population: Safety Population: All participants that received any amount of study product with complete urinalysis test performed.

The only graded urinalysis laboratory parameter was red blood cells (RBC) by complete urinalysis. The threshold for adverse events was considered as >=3. If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=2 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=3 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=4 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=3 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=3 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 21

Population: Safety Population: All participants that received any amount of study product.

Each participant is only counted once per toxicity grade for the worst severity recorded. The only ECG parameter graded was QTcF interval with a threshold of >= 30 msec. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1) through Day 21

Population: Safety Population: All participants that received any amount of study product.

Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP >= 141 mmHg or <= 89 mmHg, diastolic BP >= 91 mmHg, pulse <= 54 bpm (baseline > 60 bpm) or <=50 (baseline <= 60 bpm) or >= 101 bpm, respiratory rate >= 17 breaths per minute, and temperature >= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 Participants Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Number of Participants With Abnormal Vital Signs Pulse, Increase	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Systolic Blood Pressure, Decrease	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Signs Systolic Blood Pressure, Increase	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Diastolic Blood Pressure, Increase	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Pulse, Decrease	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal Vital Signs Respiratory Rate, Increase	4 Participants	5 Participants	5 Participants	2 Participants	4 Participants	2 Participants	6 Participants
Number of Participants With Abnormal Vital Signs Temperature, Increase	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 hours (h), 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation of VT-1598 concentrations in plasma by nominal time point.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
VT-1598 Concentrations in Plasma 0 h	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	—
VT-1598 Concentrations in Plasma 0.5 h	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	—
VT-1598 Concentrations in Plasma 1 h	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	6.417 ng/mL Standard Deviation 9.941	4.333 ng/mL Standard Deviation 6.780	8.117 ng/mL Standard Deviation 12.574	18.983 ng/mL Standard Deviation 24.670	—
VT-1598 Concentrations in Plasma 1.5 h	4.733 ng/mL Standard Deviation 7.642	7.067 ng/mL Standard Deviation 11.546	19.317 ng/mL Standard Deviation 30.014	21.100 ng/mL Standard Deviation 29.765	26.183 ng/mL Standard Deviation 21.945	43.617 ng/mL Standard Deviation 41.759	—
VT-1598 Concentrations in Plasma 2 h	9.850 ng/mL Standard Deviation 12.188	14.633 ng/mL Standard Deviation 25.117	35.400 ng/mL Standard Deviation 51.819	49.083 ng/mL Standard Deviation 47.324	56.550 ng/mL Standard Deviation 36.542	75.967 ng/mL Standard Deviation 58.528	—
VT-1598 Concentrations in Plasma 3 h	20.667 ng/mL Standard Deviation 20.704	41.400 ng/mL Standard Deviation 46.900	69.833 ng/mL Standard Deviation 104.167	92.717 ng/mL Standard Deviation 56.432	136.850 ng/mL Standard Deviation 76.482	171.700 ng/mL Standard Deviation 151.630	—
VT-1598 Concentrations in Plasma 4 h	27.180 ng/mL Standard Deviation 21.812	57.517 ng/mL Standard Deviation 56.493	75.600 ng/mL Standard Deviation 105.466	119.183 ng/mL Standard Deviation 24.982	192.900 ng/mL Standard Deviation 141.040	253.817 ng/mL Standard Deviation 193.963	—
VT-1598 Concentrations in Plasma 6 h	26.060 ng/mL Standard Deviation 12.777	55.283 ng/mL Standard Deviation 39.530	94.133 ng/mL Standard Deviation 80.855	269.000 ng/mL Standard Deviation 108.030	193.167 ng/mL Standard Deviation 96.837	289.000 ng/mL Standard Deviation 161.294	—
VT-1598 Concentrations in Plasma 8 h	19.640 ng/mL Standard Deviation 9.588	41.983 ng/mL Standard Deviation 32.838	64.300 ng/mL Standard Deviation 62.242	331.500 ng/mL Standard Deviation 167.240	128.033 ng/mL Standard Deviation 46.099	225.083 ng/mL Standard Deviation 157.281	—
VT-1598 Concentrations in Plasma 10 h	29.500 ng/mL Standard Deviation 23.021	42.850 ng/mL Standard Deviation 25.960	49.533 ng/mL Standard Deviation 57.750	253.200 ng/mL Standard Deviation 128.657	98.183 ng/mL Standard Deviation 40.408	184.950 ng/mL Standard Deviation 138.262	—
VT-1598 Concentrations in Plasma 12 h	24.650 ng/mL Standard Deviation 12.657	40.267 ng/mL Standard Deviation 19.204	41.160 ng/mL Standard Deviation 46.266	213.317 ng/mL Standard Deviation 107.529	70.817 ng/mL Standard Deviation 13.916	142.133 ng/mL Standard Deviation 111.611	—
VT-1598 Concentrations in Plasma 14 h	19.550 ng/mL Standard Deviation 7.000	30.733 ng/mL Standard Deviation 12.834	45.833 ng/mL Standard Deviation 46.048	157.517 ng/mL Standard Deviation 89.539	54.467 ng/mL Standard Deviation 12.268	105.583 ng/mL Standard Deviation 85.266	—
VT-1598 Concentrations in Plasma 24 h	12.500 ng/mL	20.200 ng/mL Standard Deviation 6.920	45.850 ng/mL Standard Deviation 50.558	68.417 ng/mL Standard Deviation 34.600	38.833 ng/mL Standard Deviation 12.325	74.917 ng/mL Standard Deviation 88.938	—
VT-1598 Concentrations in Plasma 36 h	—	16.900 ng/mL Standard Deviation 3.672	53.600 ng/mL	49.340 ng/mL Standard Deviation 20.900	35.933 ng/mL Standard Deviation 6.907	63.617 ng/mL Standard Deviation 78.709	—
VT-1598 Concentrations in Plasma 48 h	—	12.533 ng/mL Standard Deviation 1.704	48.500 ng/mL	35.720 ng/mL Standard Deviation 13.997	29.333 ng/mL Standard Deviation 9.868	76.200 ng/mL Standard Deviation 89.700	—
VT-1598 Concentrations in Plasma 60 h	—	12.750 ng/mL Standard Deviation 0.919	34.900 ng/mL	32.500 ng/mL Standard Deviation 13.927	25.467 ng/mL Standard Deviation 9.382	99.667 ng/mL Standard Deviation 93.713	—
VT-1598 Concentrations in Plasma 72 h	—	—	32.100 ng/mL	34.175 ng/mL Standard Deviation 8.730	25.860 ng/mL Standard Deviation 11.428	114.550 ng/mL Standard Deviation 77.004	—
VT-1598 Concentrations in Plasma 144 h	—	—	13.800 ng/mL	23.167 ng/mL Standard Deviation 2.901	12.833 ng/mL Standard Deviation 2.113	48.300 ng/mL Standard Deviation 17.112	—

SECONDARY outcome

Timeframe: 0 h, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation of VT-11134 concentrations in plasma by nominal time point.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
VT-11134 Concentrations in Plasma 0 h	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	—
VT-11134 Concentrations in Plasma 0.5 h	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	0.173 ng/mL Standard Deviation 0.425	0.000 ng/mL Standard Deviation 0.000	0.000 ng/mL Standard Deviation 0.000	—
VT-11134 Concentrations in Plasma 1 h	0.185 ng/mL Standard Deviation 0.453	0.000 ng/mL Standard Deviation 0.000	1.360 ng/mL Standard Deviation 2.692	2.320 ng/mL Standard Deviation 3.618	2.462 ng/mL Standard Deviation 3.858	5.213 ng/mL Standard Deviation 4.512	—
VT-11134 Concentrations in Plasma 1.5 h	2.363 ng/mL Standard Deviation 1.972	0.417 ng/mL Standard Deviation 0.662	7.052 ng/mL Standard Deviation 13.110	12.870 ng/mL Standard Deviation 19.273	10.290 ng/mL Standard Deviation 9.801	18.927 ng/mL Standard Deviation 12.740	—
VT-11134 Concentrations in Plasma 2 h	8.763 ng/mL Standard Deviation 6.556	1.575 ng/mL Standard Deviation 1.908	13.660 ng/mL Standard Deviation 23.209	25.947 ng/mL Standard Deviation 33.194	24.652 ng/mL Standard Deviation 18.888	31.732 ng/mL Standard Deviation 17.109	—
VT-11134 Concentrations in Plasma 3 h	21.508 ng/mL Standard Deviation 14.538	9.078 ng/mL Standard Deviation 8.322	25.530 ng/mL Standard Deviation 31.367	53.317 ng/mL Standard Deviation 52.224	54.845 ng/mL Standard Deviation 35.132	65.550 ng/mL Standard Deviation 31.354	—
VT-11134 Concentrations in Plasma 4 h	25.748 ng/mL Standard Deviation 16.413	17.412 ng/mL Standard Deviation 10.501	29.200 ng/mL Standard Deviation 21.290	65.700 ng/mL Standard Deviation 49.461	67.117 ng/mL Standard Deviation 40.162	86.100 ng/mL Standard Deviation 27.404	—
VT-11134 Concentrations in Plasma 6 h	25.550 ng/mL Standard Deviation 11.905	28.478 ng/mL Standard Deviation 13.949	46.750 ng/mL Standard Deviation 19.144	88.200 ng/mL Standard Deviation 36.162	71.200 ng/mL Standard Deviation 35.140	114.817 ng/mL Standard Deviation 60.895	—
VT-11134 Concentrations in Plasma 8 h	16.617 ng/mL Standard Deviation 6.486	21.208 ng/mL Standard Deviation 11.449	35.183 ng/mL Standard Deviation 15.010	97.317 ng/mL Standard Deviation 34.864	52.767 ng/mL Standard Deviation 24.493	85.283 ng/mL Standard Deviation 42.353	—
VT-11134 Concentrations in Plasma 10 h	15.968 ng/mL Standard Deviation 6.143	18.990 ng/mL Standard Deviation 9.337	27.117 ng/mL Standard Deviation 9.603	86.350 ng/mL Standard Deviation 40.901	45.200 ng/mL Standard Deviation 19.940	78.183 ng/mL Standard Deviation 33.756	—
VT-11134 Concentrations in Plasma 12 h	13.252 ng/mL Standard Deviation 4.307	16.015 ng/mL Standard Deviation 8.096	21.950 ng/mL Standard Deviation 8.474	79.083 ng/mL Standard Deviation 29.108	37.167 ng/mL Standard Deviation 17.016	60.850 ng/mL Standard Deviation 24.612	—
VT-11134 Concentrations in Plasma 14 h	11.377 ng/mL Standard Deviation 4.804	12.373 ng/mL Standard Deviation 5.510	19.017 ng/mL Standard Deviation 5.872	61.433 ng/mL Standard Deviation 18.151	30.800 ng/mL Standard Deviation 14.162	45.767 ng/mL Standard Deviation 17.898	—
VT-11134 Concentrations in Plasma 24 h	8.815 ng/mL Standard Deviation 2.712	8.382 ng/mL Standard Deviation 2.757	12.680 ng/mL Standard Deviation 3.804	35.450 ng/mL Standard Deviation 8.349	24.065 ng/mL Standard Deviation 10.721	34.950 ng/mL Standard Deviation 7.795	—
VT-11134 Concentrations in Plasma 36 h	6.910 ng/mL Standard Deviation 1.674	7.332 ng/mL Standard Deviation 2.520	12.468 ng/mL Standard Deviation 3.626	28.883 ng/mL Standard Deviation 8.619	22.122 ng/mL Standard Deviation 9.507	31.183 ng/mL Standard Deviation 8.235	—
VT-11134 Concentrations in Plasma 48 h	5.872 ng/mL Standard Deviation 1.676	5.875 ng/mL Standard Deviation 1.974	10.290 ng/mL Standard Deviation 3.267	22.833 ng/mL Standard Deviation 5.984	15.913 ng/mL Standard Deviation 7.928	27.017 ng/mL Standard Deviation 5.527	—
VT-11134 Concentrations in Plasma 60 h	6.208 ng/mL Standard Deviation 1.839	6.848 ng/mL Standard Deviation 2.578	10.890 ng/mL Standard Deviation 3.103	21.933 ng/mL Standard Deviation 5.385	17.750 ng/mL Standard Deviation 8.877	26.583 ng/mL Standard Deviation 4.522	—
VT-11134 Concentrations in Plasma 72 h	5.060 ng/mL Standard Deviation 1.682	5.580 ng/mL Standard Deviation 2.248	8.773 ng/mL Standard Deviation 2.048	18.650 ng/mL Standard Deviation 4.542	17.125 ng/mL Standard Deviation 5.810	22.550 ng/mL Standard Deviation 5.990	—
VT-11134 Concentrations in Plasma 144 h	3.817 ng/mL Standard Deviation 1.536	3.912 ng/mL Standard Deviation 1.301	6.575 ng/mL Standard Deviation 2.863	15.067 ng/mL Standard Deviation 2.522	11.732 ng/mL Standard Deviation 3.208	17.583 ng/mL Standard Deviation 5.711	—
VT-11134 Concentrations in Plasma 312 h	2.030 ng/mL Standard Deviation 0.433	3.138 ng/mL Standard Deviation 1.902	2.965 ng/mL Standard Deviation 1.575	9.965 ng/mL Standard Deviation 4.478	7.183 ng/mL Standard Deviation 2.189	9.357 ng/mL Standard Deviation 6.828	—
VT-11134 Concentrations in Plasma 480 h	—	2.010 ng/mL Standard Deviation 0.368	3.010 ng/mL Standard Deviation 0.636	5.974 ng/mL Standard Deviation 3.631	3.982 ng/mL Standard Deviation 2.234	4.122 ng/mL Standard Deviation 4.557	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 VT-1598	35.43 ng/mL Standard Deviation 17.97	63.93 ng/mL Standard Deviation 50.38	108.1 ng/mL Standard Deviation 95.57	351.0 ng/mL Standard Deviation 148.9	222.2 ng/mL Standard Deviation 121.4	322.3 ng/mL Standard Deviation 188.4	—
Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 VT-11134	30.05 ng/mL Standard Deviation 13.47	28.51 ng/mL Standard Deviation 13.89	51.02 ng/mL Standard Deviation 25.09	108.3 ng/mL Standard Deviation 44.81	73.63 ng/mL Standard Deviation 37.55	118.6 ng/mL Standard Deviation 57.53	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the dose-normalized Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 VT-1598	0.8858 (ng/mL)/mg Standard Deviation 0.4492	0.7992 (ng/mL)/mg Standard Deviation 0.6298	0.6756 (ng/mL)/mg Standard Deviation 0.5973	2.194 (ng/mL)/mg Standard Deviation 0.9307	0.6943 (ng/mL)/mg Standard Deviation 0.3793	0.5036 (ng/mL)/mg Standard Deviation 0.2945	—
Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 VT-11134	0.7513 (ng/mL)/mg Standard Deviation 0.3368	0.3564 (ng/mL)/mg Standard Deviation 0.1737	0.3189 (ng/mL)/mg Standard Deviation 0.1568	0.6769 (ng/mL)/mg Standard Deviation 0.2800	0.2301 (ng/mL)/mg Standard Deviation 0.1173	0.1853 (ng/mL)/mg Standard Deviation 0.08989	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the Tmax (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 VT-1598	5.00 h Standard Deviation 2.68	5.00 h Standard Deviation 1.10	4.83 h Standard Deviation 1.33	8.17 h Standard Deviation 3.49	5.05 h Standard Deviation 1.05	4.83 h Standard Deviation 1.33	—
Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 VT-11134	5.50 h Standard Deviation 2.51	5.67 h Standard Deviation 0.818	5.17 h Standard Deviation 1.33	7.67 h Standard Deviation 2.94	5.05 h Standard Deviation 1.05	6.33 h Standard Deviation 1.97	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the t 1/2 (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=3 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=3 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=5 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 VT-1598	5.403 h Standard Deviation 3.233	29.07 h Standard Deviation 11.31	17.11 h Standard Deviation 25.09	61.38 h Standard Deviation 54.52	40.70 h Standard Deviation 16.36	33.57 h Standard Deviation 31.79	—
Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 VT-11134	117.8 h Standard Deviation 50.49	181.7 h Standard Deviation 127.9	158.5 h Standard Deviation 90.62	249.3 h Standard Deviation 177.2	272.0 h Standard Deviation 174.7	210.7 h Standard Deviation 217.2	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the AUC(0-last) (h*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 VT-1598	214.2 h*ng/mL Standard Deviation 183.9	894.3 h*ng/mL Standard Deviation 793.1	1540 h*ng/mL Standard Deviation 2726	6293 h*ng/mL Standard Deviation 3229	4177 h*ng/mL Standard Deviation 1643	7730 h*ng/mL Standard Deviation 9144	—
Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 VT-11134	1233 h*ng/mL Standard Deviation 500.7	1551 h*ng/mL Standard Deviation 628.5	2560 h*ng/mL Standard Deviation 857.3	6838 h*ng/mL Standard Deviation 1459	5375 h*ng/mL Standard Deviation 1513	7342 h*ng/mL Standard Deviation 1866	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the dose-normalized AUC(0-last) (h*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 VT-1598	5.354 (h*ng/mL)/mg Standard Deviation 4.598	11.18 (h*ng/mL)/mg Standard Deviation 9.914	9.623 (h*ng/mL)/mg Standard Deviation 17.04	39.33 (h*ng/mL)/mg Standard Deviation 20.18	13.05 (h*ng/mL)/mg Standard Deviation 5.135	12.08 (h*ng/mL)/mg Standard Deviation 14.29	—
Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 VT-11134	30.81 (h*ng/mL)/mg Standard Deviation 12.52	19.39 (h*ng/mL)/mg Standard Deviation 7.856	16.00 (h*ng/mL)/mg Standard Deviation 5.358	42.74 (h*ng/mL)/mg Standard Deviation 9.117	16.80 (h*ng/mL)/mg Standard Deviation 4.727	11.47 (h*ng/mL)/mg Standard Deviation 2.916	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the AUC(0-inf) (h*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=1 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=3 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=5 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 VT-1598	—	—	—	—	5445 h*ng/mL Standard Deviation 2652	2797 h*ng/mL Standard Deviation 515.0	—
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 VT-11134	1960 h*ng/mL	—	3005 h*ng/mL Standard Deviation 875.4	6923 h*ng/mL Standard Deviation 1046	6260 h*ng/mL Standard Deviation 703.8	7506 h*ng/mL Standard Deviation 2357	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the dose normalized AUC(0-inf) (h*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=1 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=3 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=5 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 VT-1598	—	—	—	—	17.02 (h*ng/mL)/mg Standard Deviation 8.286	4.370 (h*ng/mL)/mg Standard Deviation 0.8047	—
Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 VT-11134	49.00 (h*ng/mL)/mg	—	18.78 (h*ng/mL)/mg Standard Deviation 5.471	43.27 (h*ng/mL)/mg Standard Deviation 6.540	19.56 (h*ng/mL)/mg Standard Deviation 2.199	11.73 (h*ng/mL)/mg Standard Deviation 3.683	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the lambda Z (1/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=1 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=3 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=5 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 VT-1598	—	—	—	—	0.01940 1/h Standard Deviation 0.009617	0.06553 1/h Standard Deviation 0.03096	—
Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 VT-11134	0.005900 1/h	—	0.006863 1/h Standard Deviation 0.001642	0.005457 1/h Standard Deviation 0.001711	0.005520 1/h Standard Deviation 0.002165	0.006034 1/h Standard Deviation 0.001700	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the CL/F (L/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=1 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=3 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=5 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 VT-1598	—	—	—	—	66.6 L/h Standard Deviation 32.4	235 L/h Standard Deviation 43.8	—
Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 VT-11134	20.4 L/h	—	56.6 L/h Standard Deviation 15.6	23.5 L/h Standard Deviation 3.50	51.5 L/h Standard Deviation 5.65	90.7 L/h Standard Deviation 21.8	—

SECONDARY outcome

Timeframe: 0 h through 480 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of the Vd/F (L) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq_adjusted (adjusted r squared) >= 0.90, span >= 2.0 half-lives, and includes at least 3 timepoints after Tmax.

Outcome measures

Measure	40 mg Fasted n=1 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=4 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=3 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=3 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=5 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 VT-1598	—	—	—	—	3440 L Standard Deviation 28.3	4200 L Standard Deviation 2010	—
Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 VT-11134	3460 L	—	8230 L Standard Deviation 1100	4450 L Standard Deviation 709	9410 L Standard Deviation 922	15400 L Standard Deviation 3820	—

SECONDARY outcome

Timeframe: 0 h through 72 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and (minimum, maximum) of the amount of VT-1598 and VT-11134 excreted into urine from time zero to the time of the last quantifiable concentration.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) VT-1598	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	—
Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) VT-11134	0.0000 mg Interval 0.0 to 0.0	0.0000 mg Interval 0.0 to 0.0	0.00004167 mg Interval 0.0 to 0.00025	0.0008970 mg Interval 0.0 to 0.00158	0.0000 mg Interval 0.0 to 0.0	0.0002200 mg Interval 0.0 to 0.00132	—

SECONDARY outcome

Timeframe: 0 h through 72 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and (minimum, maximum) of the percent of VT-1598 excreted into urine.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Percent of VT-1598 Excreted Into Urine (Ae%Dose)	0.0000 percent Interval 0.0 to 0.0	0.0000 percent Interval 0.0 to 0.0	0.0000 percent Interval 0.0 to 0.0	0.0000 percent Interval 0.0 to 0.0	0.0000 percent Interval 0.0 to 0.0	0.0000 percent Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: 0 h through 72 h post dose

Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.

Mean and standard deviation (SD) of CLr (mL/min) of VT-1598 and VT-11134.

Outcome measures

Measure	40 mg Fasted n=6 Participants 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 Participants 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 Participants 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 Participants 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 Participants 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 Participants 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
Renal Clearance (CLr) of VT-1598 and VT-11134 VT-1598	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	—
Renal Clearance (CLr) of VT-1598 and VT-11134 VT-11134	0.000 mL/min Standard Deviation 0.000	0.000 mL/min Standard Deviation 0.000	0.000460 mL/min Standard Deviation 0.00113	0.00510 mL/min Standard Deviation 0.00338	0.000 mL/min Standard Deviation 0.000	0.000957 mL/min Standard Deviation 0.00234	—

Adverse Events

40 mg Fasted

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

80 mg Fasted

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

160 mg Fasted

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

160 mg Fed

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

320 mg Fasted

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

640 mg Fasted

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	40 mg Fasted n=6 participants at risk 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	80 mg Fasted n=6 participants at risk 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fasted n=6 participants at risk 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	160 mg Fed n=6 participants at risk 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner.	320 mg Fasted n=6 participants at risk 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	640 mg Fasted n=6 participants at risk 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner.	Placebo n=12 participants at risk Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner.
General disorders Infusion site thrombosis	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Infections and infestations Respiratory tract infection viral	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood pressure diastolic increased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood pressure systolic decreased	33.3% 2/6 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Heart rate decreased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 4 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Heart rate increased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Cortisol decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 2/12 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood alkaline phosphatase increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood creatine phosphokinase increased	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	25.0% 3/12 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Basophil count increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Haemoglobin decreased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Neutrophil count decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Prothrombin time prolonged	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 2/12 • Number of events 4 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Red blood cell count decreased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations White blood cell count decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations White blood cell count increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Bilirubin conjugated increased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood glucose increased	66.7% 4/6 • Number of events 4 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	50.0% 3/6 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	50.0% 3/6 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	25.0% 3/12 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Respiratory rate increased	66.7% 4/6 • Number of events 4 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	83.3% 5/6 • Number of events 5 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	66.7% 4/6 • Number of events 7 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	50.0% 3/6 • Number of events 5 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 4/12 • Number of events 4 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Protein total decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	25.0% 3/12 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood urea increased	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Red blood cells urine positive	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood calcium decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	33.3% 2/6 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	25.0% 3/12 • Number of events 3 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood calcium increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 2/12 • Number of events 2 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood potassium decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood potassium increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood sodium decreased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	8.3% 1/12 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Investigations Blood sodium increased	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.
Nervous system disorders Headache	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	16.7% 1/6 • Number of events 1 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/6 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.	0.00% 0/12 • Day 1 (ingestion of study product) through Day 21 Any medical or laboratory condition present at the time of screening up through ingestion of the dose was considered as baseline/pre-existing condition and was not reported as an AE. If the severity of any condition increased at any time during the study after ingestion of the dose, it was recorded as an AE.

Additional Information

Dr. Cassandra Key, Senior Medical Director

ICON Early Phase Services, LLC

Phone: 210-283-4120

Email: Cassandra.key@iconplc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place