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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-02-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SXC-2023, 50 mg

Single dose of 50 mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

SXC-2023, 100 mg

Single dose of 100 mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

SXC-2023, 200 mg

Single dose of 200mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

SXC-2023, 400 mg

Single dose of 400mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

SXC-2023, 800 mg

Single dose of 800mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

SXC-2023, 1600 mg

Single dose of 1600 mg, given orally in capsule form.

Group Type EXPERIMENTAL

SXC-2023

Intervention Type DRUG

Oral capsule

Placebo oral capsule

Placebo comparator, given once orally in matching capsule form.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo given as oral capsule.

Interventions

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SXC-2023

Oral capsule

Intervention Type DRUG

Placebo oral capsule

Placebo given as oral capsule.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes