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

Huntington Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787758
• Other study ID #: 718-CLP-102 B
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: January 2022
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

This posting addresses Part B

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• SAGE-718
SAGE-718

Locations

Country	Name	City	State
United States	Sage Investigational Site	Long Beach	California
United States	Sage Investigational Site	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.		21 Days
Primary	Percentage of participants with change from baseline in vital signs.		21 Days
Primary	Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities		21 Days
Primary	Percentage of participants with change from baseline in clinical laboratory parameters.		21 Days
Primary	Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).		21 Days
Secondary	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
Secondary	PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].		17 Days
Secondary	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