A Phase I, Safety Tolerability and Pharmacokinetics of AZD4831 to Treat Cardiovascular Disease
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male
      participants, conducted at a single center. The results from this study will form the basis
      for decisions on future studies. Another purpose of this dose escalation study is to find out
      the right dose of the experimental drug to be given to study participants in future studies.
      Even though there were no harmful effects seen in the animals tested, investigator does not
      know what side effects the experimental drug might cause in humans. However, site personnel
      managing the study participants will be blinded to the extent possible and as long as
      possible to minimize any impact on data collection. Study participants will be blinded to
      treatment allocation.

      The study will be conducted in healthy participants to avoid interference from disease
      processes or other drugs.

      The participants will stay at the study center during the whole dosing period and until 48
      hours post final dose.
    

Detailed description: 
      This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male
      participants, conducted at a single center.The results from this study will form the basis
      for decisions on future studies. Another purpose of this dose escalation study is to find out
      the right dose of the experimental drug to be given to study participants in future studies.
      The study will be conducted in healthy participants to avoid interference from disease
      processes or other drugs. The participants will stay at the study center during the whole
      dosing period and until 48 hours post final dose.
    

Intervention name(s): AZD4831; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive AZD4831 once daily, orally, for a period of 10 days. Note: Additional doses (for cohorts 2,3&4) are provisional and could be adjusted based on the emerging data after the review of all available safety or other pertinent data from the previous dose by the Safety Review Committee (SRC).; Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a randomized, single-blind (site personnel to remain blinded until SRC meeting), placebo-controlled, MAD, sequential group design study in healthy male subjects, performed at a single study center. Up to 60 healthy male subjects aged 18 to 50 years (inclusive) are planned to be investigated in 4 cohorts, but up to 6 cohorts may be included if the SRC considers it necessary to repeat a dose level or if additional dose levels are required.
Up to 10 subjects will participate in each cohort. Within each cohort 8 subjects will be randomly assigned to receive AZD4831 and 2 subjects to receive placebo. AZD4831 or placebo will be administered once daily for a period of 10 days. It is anticipated this will be sufficient to achieve and maintain steady state PK profiles for several days, permitting evaluation of the safety and tolerability of multiple dose administrations at steady state. The subjects will stay at the study center during the whole dosing period and until 48h
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Oral myeloperoxidase inhibitor