A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SAGE-718 Oral Solution in Patients With Early Manifest Huntington's Disease - Part B
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/3/2019 |
| Start Date: | January 2019 |
| End Date: | June 2019 |
| Contact: | Kevin Moynihan |
| Email: | Kevin.Moynihan@sagerx.com |
| Phone: | 617-401-8123 |
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 and Patients With Early Manifest Huntington's Disease
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) and patients with early manifest Huntington's disease (Part B)
determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy
adults (Part A) and patients with early manifest Huntington's disease (Part B)
This posting addresses Part B
Inclusion Criteria:
1. Subject has early manifest Huntington's Disease with evidence of genetic mutation.
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
early manifest 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.
We found this trial at
2
sites
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