Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542435
• Other study ID #: PRO-104
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: October 2018
• Source: Promentis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multiple ascending dose 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 10, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.

2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.

3. BMI = 18.0 and = 32.0 kg/m2 at screening.

4. Medically healthy with no clinically significant screening results.

5. For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:

6. Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose

7. Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo.

8. Understands the study procedures in the informed consent form (ICF), 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 or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

3. History or presence of alcoholism or drug abuse within the past 2 years

4. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.

5. Females with a positive pregnancy test or is lactating.

6. Positive urine cotinine at screening.

7. Positive urine drug or alcohol results at screening

8. Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)

9. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

10. Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)

11. Donation of blood or significant blood loss within 56 days prior to the first dose.

12. Plasma donation within 7 days prior to the first dose.

13. Participation in another clinical study within 30 days prior to the first dose.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SXC-2023
Oral capsule
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Promentis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related adverse events	Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses	18 days
Secondary	Pharmacokinetic Assessments: Cmax	Peak plasma concentration	Up to 96 hr post dose
Secondary	Pharmacokinetic Assessments: Tmax	Time to peak plasma concentration	Up to 96 hr post dose
Secondary	Pharmacokinetic Assessments: AUC	Area under the plasma concentration-time curve	Up to 96 hr post dose