Study: NCT01913535

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CERC-501
Description: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CERC-501
Description: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: OTHER
Intervention: CERC-501
Description: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: OTHER
Intervention: CERC-501
Description: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).~High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: OTHER
Intervention: Placebo
Description: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: OTHER
Intervention: Placebo
Description: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.