Healthy Volunteers (Part 1) Clinical Trial
Official title:
A Two-part Study: Part 1 is a Multiple-dose (7-day), Open-label Evaluation of the Safety, Tolerability, and Pharmacokinetics of HT-2157 in Healthy Subjects. Part 2 is a Randomized, Double-blind, Placebo-controlled, Multiple (21-day) Ascending-dose Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-2157 in Patients With Major Depressive Disorder
| Verified date | November 2015 |
| Source | Dart NeuroScience, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
and pharmacokinetics of HT-2157 in healthy normal volunteers
Part 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose
evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in
patients with major depressive disorder
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Main Inclusion Criteria (Part 1) - No clinically relevant abnormalities - Age 18 to 55 years, inclusive - Body Mass Index (BMI) of 18.5 to 32 kg/m2 Main Inclusion Criteria (Part 2) - No clinically relevant abnormalities - Age 18 to 55 years, inclusive - Body Mass Index (BMI) of 18.5 to 32 kg/m2 - Mild-to-Moderate major depressive disorder Main Exclusion Criteria (Part 1) - Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs Main Exclusion Criteria (Part 2) - Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs - Current and primary Axis I disorder other than MDD |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Site | Glendale | California |
| Lead Sponsor | Collaborator |
|---|---|
| Dart NeuroScience, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 7-day plasma PK profile of HT-2157 | To assess the multiple dose (7-day) plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F) of HT-2157 (and its metabolite) administered in the fed state to healthy male and female subjects | 7-day | No |
| Primary | To assess the brain penetration of HT-2157 | To assess the brain penetration (PK [including Cmax, Tmax, AUC if possible] in cerebrospinal fluid [CSF]) of HT-2157 (and its metabolite) | 21-days | No |
| Primary | PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 patients with MDD | To assess the PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 administered in the fed state to patients with MDD | 21-days | No |
| Secondary | Safety and tolerability of multiple (7-day) doses of HT-2157 | To assess the safety and tolerability of multiple (7-day) doses of HT-2157 administered in the fed state to healthy male and female subjects. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events. | 7-days | Yes |
| Secondary | Safety and tolerability of multiple (21-day) ascending-doses of HT 2157 | To assess the safety and tolerability of multiple (21-day) ascending-doses of HT 2157 administered in the fed state to patients with MDD. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events. | 21-days | Yes |
| Secondary | 21-day ascending-dose plasma PK profile of HT-2157 | To assess the multiple (21-day) ascending-dose plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F, RaCmax, RaAUC) of HT-2157 (and its metabolite) administered in the fed state to patients with MDD | 21-days | No |