Clinical Trials Logo
  1. Home
  2. Healthy Participants
  3. NCT03133468

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

Healthy Participants Clinical Trial

Official title:
A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

Clinical Trial Summary

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03133468
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date July 25, 2017
Completion date July 6, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT05445440 - A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine Phase 1
Completed NCT03712540 - An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants Phase 1
Completed NCT03649165 - A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants Phase 1
Completed NCT05956002 - A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants Phase 1
Completed NCT05539976 - A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Withdrawn NCT04558216 - Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants Phase 1
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT06097390 - A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III Phase 1
Completed NCT05546151 - A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent Phase 1
Completed NCT05056246 - Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants Phase 1
Completed NCT04390776 - Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules. Phase 1
Completed NCT05074459 - A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines Phase 1
Enrolling by invitation NCT06089109 - Creating VIP Corps to Reduce Maternal Deaths N/A
Completed NCT05996250 - Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects N/A
Completed NCT03278080 - Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1 N/A
Completed NCT05064800 - PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants Phase 1
Completed NCT04471298 - A Study of Qishenyiqi Dripping Pills in Healthy Participants Phase 1
Completed NCT04914936 - A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 Phase 1
Completed NCT02882386 - Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements N/A
Completed NCT02563262 - Human Neutral Body Posture in Weightlessness N/A