A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Huntington's Disease - Part B

• Sponsor: Sage Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03787758
• Collaborator: (none)
• Enrollment: 6
• Locations: 2
• Arm: 1
• Actual Duration (Months): 7.3
• Patients Per Site: 3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)

Condition or Disease	Intervention/Treatment	Phase
Huntington Disease	Drug: SAGE-718	Phase 1

Detailed Description

This posting addresses Part B

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Healthy Adults With an Open-label Cohort of Patients With Huntington's Disease
• Actual Study Start Date: Feb 28, 2019
• Actual Primary Completion Date: Oct 7, 2019
• Actual Study Completion Date: Oct 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAGE-718	Drug: SAGE-718; SAGE-718

Outcome Measures

Primary Outcome Measures

1. Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [21 Days]

2. Percentage of participants with change from baseline in vital signs. [21 Days]

3. Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities [21 Days]

4. Percentage of participants with change from baseline in clinical laboratory parameters. [21 Days]

5. Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). [21 Days]

Secondary Outcome Measures

1. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC]. [17 Days]

2. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax]. [17 Days]

3. PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax]. [17 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is positive for mutant HTT (documented CAG repeats ≥ 40 units).

2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.

Exclusion Criteria:

1. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.

2. Subject has a history or presence of a neurologic disease or condition (other than Huntington's disease), including but not limited to severe chorea, epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.

3. Subject has a family history of epilepsy.

4. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sage Investigational Site	Long Beach	California	United States	90806
2	Sage Investigational Site	Marlton	New Jersey	United States	08053

Sponsors and Collaborators

• Sage Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sage Therapeutics
• ClinicalTrials.gov Identifier: NCT03787758
• Other Study ID Numbers: 718-CLP-102 B
• First Posted: Dec 26, 2018
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Huntington Disease

Study Results

No Results Posted as of Jan 31, 2022