Phase 1 N=24 A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Impaired Renal Function
Primary: Pharmacokinetic Parameters- Plasma AUC0-24 — 16877.94; 32787.41; 64895.29; 15506.68 ng*h/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=102 Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
Acute Bacterial Skin and Skin Structure Infection
Primary: Relative Exposure of AUC of the New Formulation to the Approved Formulation — 1470; 1460 h*µg/mL
Phase 1 N=32 Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model
Malaria
Primary: Cohort 1: Number of TEAEs — 2; 1; 4; 1 Participants
Phase 1 N=9 Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)
Multiple Myeloma
Primary: Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1 — 1 Participants
Phase 1 N=18 A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Hepatic Impairment · Healthy Participants
Primary: Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600 — 454.5; 383.6 nanogram*hour per milliliter (ng*hr/mL)
Phase 1 N=81 A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Respiratory Disorders
Primary: Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine — 382.7; 511.9; 90.5 EU/mL
Phase 1 N=76 Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
Metastatic Pancreatic Ductal Adenocarcinoma
Primary: Number of Participants With Dose Limiting Toxicities — 0; 1; 0; 0 Participants
Phase 1 N=56 Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers
Healthy
Primary: Safety and Tolerability Assessments by Vital Signs — 3; 3; 6; 6 Participants
Phase 1 N=30 Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Cervical Intraepithelial Neoplasia Grade 2/3 · High-risk HPV (Any Strain)
Primary: Number of Participants With Serious Adverse Events — 0; 0; 0; 0 Participants
Phase 1 N=27 Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) — 0; 0; 0; 0 Participants
Phase 1 N=285 Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
Hematological Malignancies
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — 58; 27; 81; 95 Participants
Phase 1 N=30 Study of Copanlisib in Hepatic or Renal Impairment
Hepatic Insufficiency, Renal Insufficiency
Primary: Maximum Observed Concentration (Cmax) of Copanlisib in Plasma. — 68.12; 71.09; 31.77; 49.20 μg/L
Phase 1 N=60 Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults
Meningococcal Vaccines
Primary: Number and Percentage of Participants Experiencing Solicited Events — 12; 10; 7; 0 Participants
Phase 1 N=12 Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Malaria,Falciparum
Primary: To Characterize the Infectivity of a New Lot of Plasmodium Falciparum Strain 3D7 Developing Parasitemia Within the Standard WRAIR CHMI Model. — 0; 1; 5; 5 Participants
Phase 1 N=75 A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
Schizophrenia
Primary: The Number of Participants Who Experienced One or More Adverse Events (AEs) — 5; 3; 4; 5 Participants