A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca
About this trial
The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
Disqualifiers
History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
Trial design
Design model
Sequential
Treatments tested in this trial
AZD3974
DrugAZD3974 will be administered as an oral solution.
Placebo
Other interventionPlacebo will be administered as an oral solution.
Treatment groups
176 Participants
are divided into 28 treatment groups28
Treatment groupsSee each treatment group below.
Group A: Part A1 (SAD) Cohort 1: AZD3974 (Dose 1)Experimental treatment 1 intervention
Group B: Part A1 (SAD) Cohort 2: AZD3974 (Dose 2)Experimental treatment 1 intervention
Group C: Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort)Experimental treatment 1 intervention
Group D: Part A1 (SAD) Cohort 4: AZD3974 (Dose 4)Experimental treatment 1 intervention
Group E: Part A1 (SAD) Cohort 5: AZD3974 (Dose 5)Experimental treatment 1 intervention
Group F: Part A1 (SAD) Cohort 6: AZD3974 (Dose 6)Experimental treatment 1 intervention
Group G: Part A1 (SAD) optional additional Cohort 7: AZD3974Experimental treatment 1 intervention
Group H: Part A1 (SAD) optional additional Cohort 8: AZD3974Experimental treatment 1 intervention
Group I: Part A1 (SAD) Cohort: PlaceboPlacebo comparator 1 intervention
Group J: Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort)Placebo comparator 1 intervention
Group K: Part A2 (SAD) Japanese Cohort 1: AZD3974Experimental treatment 1 intervention
Group L: Part A2 (SAD) Japanese Cohort 2: AZD3974Experimental treatment 1 intervention
Group M: Part A2 (SAD) Japanese Cohort 3: AZD3974Experimental treatment 1 intervention
Group N: Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974Experimental treatment 1 intervention
Group O: Part A2 (SAD) Japanese Cohort: PlaceboPlacebo comparator 1 intervention
Group P: Part A3 (SAD) Chinese Cohort 1: AZD3974Experimental treatment 1 intervention
Group Q: Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974Experimental treatment 1 intervention
Group R: Part A3 (SAD) Chinese Cohort: PlaceboPlacebo comparator 1 intervention
Group S: Part B1 (MAD) Cohort 1: AZD3974Experimental treatment 1 intervention
Group T: Part B1 (MAD) Cohort 2: AZD3974Experimental treatment 1 intervention
Group U: Part B1 (MAD) Cohort 3: AZD3974Experimental treatment 1 intervention
Group V: Part B1 (MAD) Cohort 4: AZD3974Experimental treatment 1 intervention
Group W: Part B1 (MAD) optional additional Cohort 5: AZD3974Experimental treatment 1 intervention
Group X: Part B1 (MAD) optional additional Cohort 6: AZD3974Experimental treatment 1 intervention
Group Y: Part Bl (MAD) Cohort: PlaceboPlacebo comparator 1 intervention
Group Z: Part B2 (MAD) Japanese Cohort 1: AZD3974Experimental treatment 1 intervention
Group [: Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974Experimental treatment 1 intervention
Group \: Part B2 (MAD) Japanese Cohort: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Time frame
Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14Secondary outcomes
1
Part A and Part B: Plasma concentrations of AZD3974
To characterize the plasma concentrations of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Time frame
Part A: Day 1 to Day 2; Part B: Day 1 to Day 92
Part A1-Cohort 3: Plasma concentrations of AZD3974
To assess the impact of food (fed) on the single-dose plasma concentrations of AZD3974
Time frame
Day 1 to Day 43
Part A and Part B: Urine concentrations of AZD3974
To characterize the urine concentration of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Time frame
Part A: Day 1; Part B: Day 1 and Day 74
Part A1-Cohort 3: Urine concentrations of AZD3974
To assess the impact of food (fed) on the single-dose urine concentrations of AZD3974
Time frame
Day 1 and Day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
Parexel
Collaborator
Source ClinicalTrials.gov