Phase I Clinical Trial Experience
Below is a cumulative list of Page I Trials
A Phase I,
Pharmacokinetic, Pharmacodynamic, and Safety evaluation of Tirofiban Using a Single High-Dose Bolus in Subjects with Normal Renal Function and Subjects with Moderate-to-Severe Renal Impairment with Non-Dialysis Dependent Renal Insufficiency (NDDRI).
A Phase I,
Open-label, Single Dose, Parallel-group Study to Evaluate the Pharmacokinetics of Palbociclib (XXXXX) In Subjects with Impaired Renal Function.
A Phase I,
Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of XXXXX in Postmenopausal Women with Symptoms of Vulvar and Vaginal Atrophy (VVA).
A Phase I,
Single Dose, Open-Label Study to Evaluate the Effect of Renal Impairment on The Pharmacokinetics Of XXXXX.
A Phase I B,
2-week, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Dose-Escalating Study with XXXXX And One Dose of Spironolactone to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects with Type 2 Diabetes Mellitus and Albuminuria.
A Phase I B,
Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety Of 4-Week Administration of Multiple Oral Doses of XXXXX In Type 2 Diabetes Mellitus Subjects with Insufficient Glycemic Control on Metformin.
A Phase I B,
Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study to Characterize the Pharmacodynamics And Tolerability Of Two Dosing Regimens Of XXXXX In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin.
A Phase I B,
Randomized, Single-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of XXXXX in Subjects with Chronic Hepatitis C Virus Infection.
A Phase I B,
Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of XXXXX in Subjects with Chronic Hepatitis C Virus Infection.
A Phase I,
Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of XXXXX in Subjects with Hepatic Impairment Compared to Subjects with Normal Hepatic Function.
A Phase I,
Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Crizotinib (XXXXX) In Subjects With Impaired Renal Function.
A Phase I,
Open Label, Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin 5 mg After Single and Multiple Oral Administration in Patients with Type 2 Diabetes Mellitus of African American Origin for 7 Days.
A Phase I,
Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of XXXXX in Subjects with Severe Renal Impairment and in Matched Healthy Volunteers.
A Phase I,
Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of XXXXX in Subjects with Hepatic Impairment and in Matched Healthy Volunteers.
A Phase I,
Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Effect of A Single Dose Of XXXXX, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects.
A Phase I,
Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of XXXXX in Subjects with Normal and Impaired Renal Function.
A Phase I,
Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of XXXXX in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
A Phase I,
Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study to Assess the Safety, Tolerability, And Pharmacokinetics of XXXXX In Subjects with Type 2 Diabetes Mellitus.
A Phase I,
Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of XXXXX in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
A Phase I,
Placebo-controlled, Randomized Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Iv Doses of XXXXX In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin.
A Phase I / II,
Adaptive Design Trial to Evaluate the Immunogenicity and Safety of Panblok (H7 rHA) at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared with Unadjuvanted H7 rHA in Healthy Adults Aged 18 and Older.