Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | July 2011 |
| End Date: | December 2012 |
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
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
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
This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability,
and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers
Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation
of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in
patients with major depressive disorder. The primary objective of Part 2 is to assess the
CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of
HT-2157 in this patient population may be assessed using exploratory biologic and
pharmacodynamic markers of potential efficacy
and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers
Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation
of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in
patients with major depressive disorder. The primary objective of Part 2 is to assess the
CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of
HT-2157 in this patient population may be assessed using exploratory biologic and
pharmacodynamic markers of potential efficacy
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
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