Phase 1: First in man; Dose Escalation, and PK/PD Studies
The PROMETRIKA team has proven expertise in the full range of specialized CRO services necessary for Phase 1 studies including pharmacokinetic and pharmacodynamic studies (PK/PD), first-in-man and dose escalation studies. Our project managers, clinical monitors, and data managers have extensive experience working with Phase 1 units and specialty core laboratories in the U.S. and abroad. Our statisticians have conducted analyses of PK and PD parameters as well as specialized Phase 1 studies including thorough QTc studies. We can conduct statistical analyses based on available PK and PD parameters, or calculate parameters based on plasma or urine concentration data using WinNonlin® or our own SAS® programs. Our team of specialists has developed customized programs to perform PK/PD modeling and to evaluate dose-proportionality. The PROMETRIKA medical writing staff has authored multiple stand-alone Phase 1 reports as well as several comprehensive clinical study reports. Our own PK/PD consultant is available to provide essential support for analyses and development of clinical study reports. In these efforts we often work in collaboration with a sponsor’s internal clinical pharmacology department or external consultants.
Highlights from recent PROMETRIKA Phase 1 experience include:
| Therapeutic Area | Indication | Sample Size | Study Design |
|---|---|---|---|
| Allergy | Allergic Rhinitis | 10 | single-dose, crossover, open-label study |
| Allergy | Allergic Rhinitis | 25 | single-dose, crossover, open-label study |
| Allergy | Allergic Rhinitis | 30 | multiple-dose, crossover, open-label study |
| Allergy | Allergic Rhinitis | 20 | single-dose, parallel group, open-label study |
| Allergy | Allergic Rhinitis | 30 | multiple-dose, parallel group, open-label study |
| Anti-Infective | Healthy Subjects (Anti-bacterial) | 100 | double-blind, randomized, controlled study with six sequential cohorts |
| Anti-Infective | Healthy Subjects (Anti-fungal) | 150 | two-tier randomized, double-blind, placebo-
and active- controlled, parallel design study |
| Anti-Infective | Healthy Subjects (Anti-fungal) | 100 | double-blind, placebo-controlled, sequential, ascending, single, multiple loading and maintenance doses study |
| Anti-Infective | Healthy Subjects (Sepsis) | 10 | single center, non-randomized, open-label study |
| Anti-Infective | Healthy Subjects (Anti-fungal) | 30 | open-label study |
| Anti-Infective | Healthy Subjects (Anti-bacterial) | 30 | double-blind, randomized, placebo-controlled study with two cohorts |
| Cardiology | Healthy Subjects (Hypercholesterolemia) | 30 | single-center, randomized, double-blind, placebo-controlled, single ascending dose study |
| Cardiology | Healthy Subjects (Hypercholesterolemia) | 150 | single-center, randomized, double-blind, placebo- and active-controlled, repeat ascending dose study |
| Cardiology | Healthy Subjects (Platelet Function Disorders) | 50 | single-center, double-blind, randomized, dose escalation study |
| Cardiology | Thoracic Stent Graft | 50 | single arm study |
| Dermatology | Pressure Ulcers | 10 | open-label safety study |
| Dermatology | Pressure Ulcers | 25 | randomized, blinded-assessor, controlled study |
| Dermatology | Psoriasis | 40 | randomized, double-blind, placebo-controlled, within subject, ascending dose study |
| Dermatology | Plaque Psoriasis | 10 | single-dose, two-way crossover |
| Gastroenterology | Healthy Subjects (IBS-C and CC) | 20 | randomized, open-label, two-period, two-sequence, crossover study |
| Gastroenterology | Healthy Subjects (IBS-C) | 80 | double-blind, randomized, placebo-controlled, sequential group, ascending single-dose study |
| Gastroenterology | Healthy Subjects (GERD) | 40 | open-label, randomized, parallel, multiple-dose study |
| Gastroenterology | Healthy Subjects (GERD) | 40 | randomized, double-blind, placebo-controlled, sequential, ascending single-dose study |
| Neurology | Healthy Subjects (Acute Pain) | 70 | single-center, randomized, positive and placebo controlled, four–way, four period, crossover study |
| Neurology | Healthy Subjects (Acute Pain) | 15 | open-label, single-dose study |
| Neurology | Healthy Subjects (Parkinson's Disease) | 15 | open-label, single-dose, four-period study with a randomized two-way crossover during periods 2 and 3 |
| Oncology | Prostate Cancer Diagnostic Imaging | 10 | single-blind, randomized, crossover design |
| Oncology | Prostate Cancer | 10 | open-label study |
| Oncology | Healthy Subjects (Prostate Cancer) | 5 | single arm, open-label study |
| Oncology | Melanoma | 10 | single-dose, open-label study |
| Oncology | Hematologic Malignancies | 40 | single-center, dose escalation study |
| Oncology | Solid Tumors or Lymphomas | 70 | open-label, non-randomized, multicenter, dose escalation study |
| Oncology | GI or Lung Cancer | 80 | open-label, non-randomized, dose-finding study |
| Oncology | Renal cell carcinoma | 25 | open-label, single-center, pilot study |
| Oncology | Solid Tumors | 50 | open-label, two-arm, dose finding study |
| Oncology | Solid Tumors | 40 | two-arm, open-label, non-randomized, dose escalation study |
| Oncology | Advanced Solid Tumors | 60 | open-label, dose escalation study |
| Pulmonary | Asthma | 10 | single-center, randomized, single-dose, crossover study |
| Pulmonary | Asthma | 25 | randomized, single-center, single-dose, three-period crossover study |
| Pulmonary | Asthma | 30 | randomized, single-center, multiple-dose, three-period crossover study |
| Pulmonary | COPD | 25 | double-blind, placebo-controlled, single-dose, crossover study |
| Pulmonary | COPD | 10 | double-blind, placebo-controlled, single-dose, crossover study |
| Pulmonary | COPD | 25 | double-blind, placebo-controlled, single-dose, crossover study |
| Pulmonary | COPD | 10 | double-blind, placebo-controlled, single-dose, crossover study |
| Pulmonary | Healthy Subjects (Cystic Fibrosis) | 30 | double-blind, placebo-controlled, single-center, randomized, two-sequence, two-period crossover study |
| Rheumatology | Healthy Subjects (Rheumatoid Arthritis) | 60 | double-blind, placebo-controlled, randomized, multiple ascending dose study |
| Rheumatology | Healthy Subjects (Rheumatoid Arthritis) | 70 | single ascending dose, double-blind, placebo-controlled, randomized study |