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Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of SXC-2023 When Administered Orally to Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03301298
Enrollment
48
Registered
2017-10-04
Start date
2017-09-11
Completion date
2018-02-13
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Interventions

DRUGSXC-2023

Oral capsule

DRUGPlacebo oral capsule

Placebo given as oral capsule.

Sponsors

Celerion
CollaboratorINDUSTRY
Promentis Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive). 2. Medically healthy with no clinically significant screening results. 3. Non-vasectomized male subjects must agree to use birth control or abstain from sexual intercourse during and until 90 days beyond the last dose of study drug/placebo. 4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study. 5. Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion criteria

1. Subject is mentally or legally incapacitated. 2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subjects by their participation in the study. 3. History or presence of alcoholism or drug abuse within the past 2 years 4. Female subject of childbearing potential. 5. Blood donation or significant blood loss within 56 days prior to first dose. 6. Plasma donation within 7 days prior to first dose. 7. Participation in another clinical trial within 30 days prior to first dose.

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects Experiencing TEAEs.8 daysTreatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.

Secondary

MeasureTime frameDescription
Pharmacokinetic Assessments: CmaxSamples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Peak plasma concentration
Pharmacokinetics Assessments: TmaxSamples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Time to peak plasma concentration
Pharmacokinetic Assessments: AUCSamples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Area under the plasma concentration-time curve
Pharmacokinetic: Food Effect, AUCSamples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.
Pharmacokinetic: Food Effect, CMaxSamples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

Countries

United States

Participant flow

Participants by arm

ArmCount
SXC-2023, 50 mg
Single dose of 50 mg, given orally in capsule form. SXC-2023: Oral capsule
6
SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form. SXC-2023: Oral capsule
6
SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form. SXC-2023: Oral capsule
6
SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form. SXC-2023: Oral capsule
6
SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form. SXC-2023: Oral capsule
6
SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form. SXC-2023: Oral capsule
6
Placebo
Placebo comparator, given once orally in matching capsule form. Placebo oral capsule: Placebo given as oral capsule.
12
Total48

Baseline characteristics

CharacteristicTotalSXC-2023, 50 mgSXC-2023, 200 mgSXC-2023, 400 mgSXC-2023, 800 mgSXC-2023, 1600 mgSXC-2023, 100 mgPlacebo
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
48 Participants6 Participants6 Participants6 Participants6 Participants6 Participants6 Participants12 Participants
Age, Continuous41.3 years
STANDARD_DEVIATION 10.15
40.5 years
STANDARD_DEVIATION 11.26
43.3 years
STANDARD_DEVIATION 9.35
42.8 years
STANDARD_DEVIATION 14.41
38.7 years
STANDARD_DEVIATION 9.09
40 years
STANDARD_DEVIATION 5.73
38 years
STANDARD_DEVIATION 13.93
43.3 years
STANDARD_DEVIATION 9.43
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants4 Participants4 Participants5 Participants5 Participants6 Participants3 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants2 Participants2 Participants1 Participants1 Participants0 Participants3 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
43 Participants5 Participants6 Participants6 Participants6 Participants6 Participants3 Participants11 Participants
Region of Enrollment
United States
48 participants6 participants6 participants6 participants6 participants6 participants6 participants12 participants
Sex: Female, Male
Female
23 Participants3 Participants4 Participants3 Participants2 Participants3 Participants2 Participants6 Participants
Sex: Female, Male
Male
25 Participants3 Participants2 Participants3 Participants4 Participants3 Participants4 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 60 / 60 / 60 / 60 / 60 / 12
other
Total, other adverse events
3 / 60 / 64 / 61 / 62 / 61 / 64 / 12
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 60 / 60 / 60 / 12

Outcome results

Primary

Number of Subjects Experiencing TEAEs.

Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.

Time frame: 8 days

ArmMeasureValue (NUMBER)
SXC-2023, 50 mgNumber of Subjects Experiencing TEAEs.3 participants
SXC-2023, 100 mgNumber of Subjects Experiencing TEAEs.0 participants
SXC-2023, 200 mgNumber of Subjects Experiencing TEAEs.4 participants
SXC-2023, 400 mgNumber of Subjects Experiencing TEAEs.1 participants
SXC-2023, 800 mgNumber of Subjects Experiencing TEAEs.2 participants
SXC-2023, 1600 mgNumber of Subjects Experiencing TEAEs.1 participants
Placebo Oral CapsuleNumber of Subjects Experiencing TEAEs.4 participants
Secondary

Pharmacokinetic Assessments: AUC

Area under the plasma concentration-time curve

Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
SXC-2023, 50 mgPharmacokinetic Assessments: AUC3213 ng*hr/mLGeometric Coefficient of Variation 154.1
SXC-2023, 100 mgPharmacokinetic Assessments: AUC9732 ng*hr/mLGeometric Coefficient of Variation 73.9
SXC-2023, 200 mgPharmacokinetic Assessments: AUC25180 ng*hr/mLGeometric Coefficient of Variation 43.2
SXC-2023, 400 mgPharmacokinetic Assessments: AUC57170 ng*hr/mLGeometric Coefficient of Variation 54
SXC-2023, 800 mgPharmacokinetic Assessments: AUC139500 ng*hr/mLGeometric Coefficient of Variation 28.6
SXC-2023, 1600 mgPharmacokinetic Assessments: AUC239700 ng*hr/mLGeometric Coefficient of Variation 29.8
Secondary

Pharmacokinetic Assessments: Cmax

Peak plasma concentration

Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
SXC-2023, 50 mgPharmacokinetic Assessments: Cmax758.2 ng/mLGeometric Coefficient of Variation 157.3
SXC-2023, 100 mgPharmacokinetic Assessments: Cmax2181 ng/mLGeometric Coefficient of Variation 58.3
SXC-2023, 200 mgPharmacokinetic Assessments: Cmax5145 ng/mLGeometric Coefficient of Variation 38.1
SXC-2023, 400 mgPharmacokinetic Assessments: Cmax9005 ng/mLGeometric Coefficient of Variation 60.4
SXC-2023, 800 mgPharmacokinetic Assessments: Cmax25510 ng/mLGeometric Coefficient of Variation 49.5
SXC-2023, 1600 mgPharmacokinetic Assessments: Cmax33700 ng/mLGeometric Coefficient of Variation 35
Secondary

Pharmacokinetic: Food Effect, AUC

To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

Population: Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate.~Subject 5004 received fasted treatment but discontinued prior to fed treatment.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
SXC-2023, 50 mgPharmacokinetic: Food Effect, AUC158700 ng*hr/mLGeometric Coefficient of Variation 31.4
Secondary

Pharmacokinetic: Food Effect, CMax

To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.

Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

Population: Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate.~Subject 5004 received fasted treatment but discontinued prior to fed treatment.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
SXC-2023, 50 mgPharmacokinetic: Food Effect, CMax17160 ng/mLGeometric Coefficient of Variation 26.3
Secondary

Pharmacokinetics Assessments: Tmax

Time to peak plasma concentration

Time frame: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.

Population: Subject 1008 who received Treatment A in Cohort 1 did not have any measureable concentration of SXC-2023, NAC, or p-toluic acid and was excluded from the PK population.

ArmMeasureValue (MEAN)
SXC-2023, 50 mgPharmacokinetics Assessments: Tmax3.111 hours
SXC-2023, 100 mgPharmacokinetics Assessments: Tmax3.016 hours
SXC-2023, 200 mgPharmacokinetics Assessments: Tmax4 hours
SXC-2023, 400 mgPharmacokinetics Assessments: Tmax4 hours
SXC-2023, 800 mgPharmacokinetics Assessments: Tmax2.501 hours
SXC-2023, 1600 mgPharmacokinetics Assessments: Tmax3.5 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026