Conditions: Phase 1 Pharmacodynamic Study
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief summary:
This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Detailed description:
Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Arms:
arm 1: Intervention: Oral rsCT tablet given once 4 hours after evening meal. arm 2: Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal arm 3: Intervention: Oral rsCT tablet given once 2 hours after evening meal. arm 4: Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal

Interventions: intervention 1: Oral rsCT tablet intervention 2: Oral Placebo Tablet intervention 3: Oral rsCT tablet intervention 4: Fortical (rsCT) nasal spray
Intervention descriptions: intervention 1: On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description. intervention 2: Part 1, Double blind oral placebo tablet given once 4 hours after evening meal. intervention 3: Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal. intervention 4: Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.

Protocol document: