Phase 1 N=21 JOTROL PK, Safety, and Food Effect Assessment
Pharmacokinetics · Safety · Food-drug Interaction
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7; 4; 6; 6 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=59 Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Alcohol Drinking
Primary: Occupancy of KOR by NTX and Drinking — 92 % Occupancy
Phase 1 N=26 Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
HIV-1 Infection
Primary: Percent of Participants With a Grade 3 or Higher Treatment-Related Adverse Event (AE) — 43; 14; 0; 0 percentage of participants
Phase 1 N=25 Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
Recurrent Plasma Cell Myeloma · Refractory Plasma Cell Myeloma
Primary: Dose-limiting Toxicities (DLT) Rate — 0; 0; 1; 0 Participants
Phase 1 N=21 Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production
Empaglifozin · Physiological Effects of Drugs · Hypoglycemic Agents
Primary: Change in Serum β-hydroxybutyrate (BHB) — 40.717 µM — p=<0.001
Phase 1 N=20 The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
Opioid Use Disorder
Primary: Percentage of Participants That Maintain MEC — 10 Participants
Phase 1 N=8 Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
Healthy
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study — 0; 3; 0; 0…
Phase 1 N=78 Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis
Atopic Dermatitis · Healthy Volunteers
Primary: Number of Participants With Adverse Events — 3; 5; 1; 6 Participants
Phase 1 N=21 Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
Healthy Subjects · Opioid Antagonist · Pharmacokinetics
Primary: First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (1 Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min)…
Phase 1 N=48 The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Migraine · Migraine;Menstrual · Contraception
Primary: Serum Etonogestrel Concentrations — 142.0; 126.0; 119.0; 105.0 pg/mL
Phase 1 N=30 A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 2; 2; 9; 12 Participants
Phase 1 N=60 This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam
Healthy
Primary: Percentage of Participants With Drug-related Adverse Events — 20.0; 50.0; 12.5; 0.0 Percentage of participants (%)
Phase 1 N=27 Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
HIV Infections
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 5; 6; 6; 7 Participants
Phase 1 N=12 A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood
Healthy
Primary: Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm) — 44.63; 0.22…
Phase 1 N=91 Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Healthy
Primary: Number of Participants With Drug-related Adverse Events (AEs) — 3; 1; 4; 1 Participants