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

Promentis Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SXC-2023; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301298

PRO-101

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 7 patient groups, including a placebo group

SXC-2023, 50 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

SXC-2023, 100 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

SXC-2023, 200 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

SXC-2023, 400 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

SXC-2023, 800 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

SXC-2023, 1600 mg

Experimental group

Description:

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

Treatment:

Drug: SXC-2023

Placebo oral capsule

Placebo Comparator group

Description:

Placebo comparator, given once orally in matching capsule form.

Treatment:

Drug: Placebo oral capsule