Back to results

Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

Primary Purpose

Parkinson's Disease

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

XC130-A10H

Placebo

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Major Inclusion Criteria:

Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age.
Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

Major Exclusion Criteria:

Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
History or presence of clinically significant medical, surgical or psychiatric condition or disease.
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 subject by their participation in the study.
History of clinically significant hypotension.
History of orthostatic hypotension in the 12 months prior to screening.
Clinically significant hypertension at screening.
History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

XC130-A10H

Placebo

Arm Description

XC130-A10H (single dose)

placebo (single dose)

Outcomes

Primary Outcome Measures

Incidence and severity of Adverse Events

Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.

Changes from baseline in systolic and diastolic blood pressure

Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.

Secondary Outcome Measures

Maximum plasma concentration [Cmax] of XC13-A10H

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.

Area under the curve [AUC] of XC130-A10H

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite.

Time to reach the maximum plasma concentration [Tmax] of XC130-A10H

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC130-A10H and primary metabolite will be calculated.

Full Information

NCT ID

NCT04043338

First Posted

July 24, 2019

Last Updated

September 16, 2021

Sponsor

Xoc Pharmaceuticals

Collaborators

Celerion

1. Study Identification

Unique Protocol Identification Number

NCT04043338

Brief Title

Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 11, 2019 (Actual)

Primary Completion Date

January 30, 2022 (Anticipated)

Study Completion Date

April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xoc Pharmaceuticals

Collaborators

Celerion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Detailed Description

This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. Safety (i.e., adverse events [AEs], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale [C-SSRS], and Mini-Mental State Examination [MMSE]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XC130-A10H

Arm Type

Experimental

Arm Description

XC130-A10H (single dose)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo (single dose)

Intervention Type

Drug

Intervention Name(s)

XC130-A10H

Intervention Description

XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo supplied as matching capsules or tablets

Primary Outcome Measure Information:

Title

Incidence and severity of Adverse Events

Description

Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.

Time Frame

pre-dose through 14 days post-dose

Title

Changes from baseline in systolic and diastolic blood pressure

Description

Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.

Time Frame

pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours

Secondary Outcome Measure Information:

Title

Maximum plasma concentration [Cmax] of XC13-A10H

Description

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated.

Time Frame

48 hours

Title

Area under the curve [AUC] of XC130-A10H

Description

Time Frame

48 hours

Title

Time to reach the maximum plasma concentration [Tmax] of XC130-A10H

Description

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Major Inclusion Criteria: Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age. Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening. Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs. Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol. Major Exclusion Criteria: Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study. History or presence of clinically significant medical, surgical or psychiatric condition or disease. 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 subject by their participation in the study. History of clinically significant hypotension. History of orthostatic hypotension in the 12 months prior to screening. Clinically significant hypertension at screening. History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Fishman, MD

Organizational Affiliation

Xoc Consulting Chief Medical Officer

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

We'll reach out to this number within 24 hrs