18 results
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
Primary: To demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) over 48 weeks in HIV-1 infected antiretroviral therapy (ART) experienced subjects.…
Part I (dose-escalation): to evaluate the safety of SYD985 and to determine the Maximum Tolerated Dose and Recommended Phase 2 DosePart II (expanded cohorts): to evaluate the Objective tumour Response Rate
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
The primary objective is to assess the relative bioavailability of TMC207 after single-dose administration of 100 mg of TMC207 as water dispersible tablets or granules using a 100-mg tablet formulation as the reference, with and without food.
The objectives of this study are to:• Evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in adult patients with facioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical…
The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
Primary objectives:*To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 when administered as a 21-day or 28 day CIV infusion to patients with refractory hematologic malignancies.*To assess the safety and…
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…
To characterize the single-dose pharmacokinetic (PK) of RPV after SC administration of RPV LA suspensions with different doses and/or different particle size (PS) to support further dose and formulation selection, in healthy adult participants.To…
Diabetic Macular Ischemia (DMI) is a complication of diabetic retinopathy (DR) and can lead to vision loss. Currently, there are no approved or effective treatments to prevent either onset or progression of DMI in DR patients.As a transition from…
Primary:To demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks compared to remaining on ABC/DTG/3TC (or DTG and an approved dual-NRTI scheme) over 48 weeks.Secondary:To…
Primary:To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two months compared to a BIK single tablet regimen administered once daily over 12 months in suppressed HIV-1 infected antiretroviral therapy (ART)-experienced…
The overall objective of the CAB LA + RPV LA clinical development programme is to develop a highly effective, well-tolerated, two-drug, long-acting injectable regimen which has the potential to offer improved treatment convenience, compliance and…
The primary objective is to evaluate the safety, tolerability, and doselimiting toxicities, and determine the recommended dose for expansionof INCA00186 as monotherapy and of combination treatments of INCA00186 with retifanlimab and/or INCB106385 in…
The primary objective of this study is to demonstrate that SYD985 is superior to physician*s choice in prolonging progression-free survival (PFS) on the basis of the blinded independent central review of tumour assessment.The secondary objectives of…