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

NCT03301298 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PRO-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  8 days

Secondary Outcomes (5)

• Pharmacokinetic Assessments: Cmax

  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.

• Pharmacokinetics Assessments: Tmax

  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.

• Pharmacokinetic Assessments: AUC

  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.

• Pharmacokinetic: Food Effect, AUC

  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.

• Pharmacokinetic: Food Effect, CMax

  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.

Study Arms (7)

SXC-2023, 50 mg

EXPERIMENTAL

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

Drug: SXC-2023

SXC-2023, 100 mg

EXPERIMENTAL

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

Drug: SXC-2023

SXC-2023, 200 mg

EXPERIMENTAL

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

Drug: SXC-2023

SXC-2023, 400 mg

EXPERIMENTAL

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

Drug: SXC-2023

SXC-2023, 800 mg

EXPERIMENTAL

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

Drug: SXC-2023

SXC-2023, 1600 mg

EXPERIMENTAL

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

Drug: SXC-2023

Placebo oral capsule

PLACEBO COMPARATOR

Placebo comparator, given once orally in matching capsule form.

Drug: Placebo oral capsule

Interventions

SXC-2023 DRUG

Oral capsule

SXC-2023, 100 mg; SXC-2023, 1600 mg; SXC-2023, 200 mg; SXC-2023, 400 mg; SXC-2023, 50 mg; SXC-2023, 800 mg

Placebo oral capsule DRUG

Placebo given as oral capsule.

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or females (women of non child bearing potential), 18-55 years of age (inclusive).
• Medically healthy with no clinically significant screening results.
• 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.
• Continuous non-smoker, at least 3 months prior to first dose and throughout the study.
• Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

You may not qualify if:

• Subject is mentally or legally incapacitated.
• 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.
• History or presence of alcoholism or drug abuse within the past 2 years
• Female subject of childbearing potential.
• Blood donation or significant blood loss within 56 days prior to first dose.
• Plasma donation within 7 days prior to first dose.
• Participation in another clinical trial within 30 days prior to first dose.

Sponsors & Collaborators

• Promentis Pharmaceuticals, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Results Point of Contact

• Title: Dean Brostowin
• Organization: Promentis Pharmaceuticals

dbrostowin@promentispharma.com

617-300-6172

Study Officials

• Tricia Cotter

  Promentis Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: September 11, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)