Study identifier:D6580C00004
ClinicalTrials.gov identifier:NCT03136991
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4831 after Multiple Ascending Dose Administration to Healthy Male Subjects
cardiovascular disease
Phase 1
Yes
AZD4831, Placebo
Male
38
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Jan 2020 by AstraZeneca
AstraZeneca
PAREXEL
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.
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.
Location
Location
Glendale, CA, United States, 91206
Arms | Assigned Interventions |
---|---|
Active Comparator: Cohort 1 Participants will receive AZD4831 5 mg/placebo oral suspension. | Drug: AZD4831 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). Drug: Placebo Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days. |
Active Comparator: Cohort 2 Participants will receive AZD4831 (Additional dose 1)/placebo oral suspension. | Drug: AZD4831 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). Drug: Placebo Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days. |
Active Comparator: Cohort 3 Participants will receive AZD4831 (Additional dose 2)/placebo oral suspension. | Drug: AZD4831 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). Drug: Placebo Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days. |
Active Comparator: Cohort 4 Participants will receive AZD4831 (Additional dose 3)/placebo oral suspension. | Drug: AZD4831 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). Drug: Placebo Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days. |
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