AZD8965 for Healthy Subjects
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: AstraZeneca
Must not be taking: Hormonal contraceptives
Disqualifiers: Diabetes, Hypertension, Cardiovascular, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess the effect of food on the safety, tolerability, and PK of orally administered AZD8965.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be healthy without any ongoing medical conditions or medications that could interfere with the study.
Eligibility Criteria
This trial is for healthy individuals, including those of Japanese and Chinese descent. It's designed to test the safety and how the body processes a new drug called AZD8965, both on an empty stomach and with food.Inclusion Criteria
I am not breastfeeding and agree to use effective birth control if I'm sexually active.
I am a woman who cannot become pregnant, confirmed by a doctor.
I am a man who can father children and will use birth control as required.
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Exclusion Criteria
I have a history of high blood pressure or heart disease.
I have a long-term infection or am at high risk for infections.
I do not have chronic conditions that affect drug metabolism.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Single Ascending Dose (SAD)
Participants receive a single dose of AZD8965 or placebo to assess safety, tolerability, and pharmacokinetics
1 week
Residential stay from Day -1 to at least 72 hours post-dose
Multiple Ascending Dose (MAD)
Participants receive multiple doses of AZD8965 or placebo to assess safety, tolerability, and pharmacokinetics
2 weeks
Residential stay from Day -1 to at least 48-72 hours post last dose
Food Effect
Participants receive AZD8965 under fasted and fed conditions to assess the effect of food on pharmacokinetics
1 week
Residential stay from Day -1 to at least 72 hours post-dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- AZD8965 (Other)
Trial OverviewThe study involves giving participants either AZD8965 or a placebo (a substance with no active drug). They'll receive varying doses to see how well they tolerate it and how their bodies handle the drug over time.
Participant Groups
14Treatment groups
Experimental Treatment
Group I: Part 4: Food Effect Cohort - AZD8965Experimental Treatment1 Intervention
Participants will receive 2 single dose treatments of AZD8965 \[following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)\].
Group II: Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Group III: Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Group IV: Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Group V: Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Group VI: Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Group VII: Part 2: MAD Cohort 3 - AZD8965 (Dose 3)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8.
Group VIII: Part 2: MAD Cohort 2 - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8.
Group IX: Part 2: MAD Cohort 1 - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8.
Group X: Part 1: SAD Cohort 5 - AZD8965 (Dose 5)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1.
Group XI: Part 1: SAD Cohort 4 - AZD8965 (Dose 4)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1.
Group XII: Part 1: SAD Cohort 3 - AZD8965 (Dose 3)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1.
Group XIII: Part 1: SAD Cohort 2 - AZD8965 (Dose 2)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Group XIV: Part 1: SAD Cohort 1 - AZD8965 (Dose 1)Experimental Treatment2 Interventions
Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteGlendale, CA
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
References
Adverse drug reactions: definitions, diagnosis, and management. [2022]We define an adverse drug reaction as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product." Such reactions are currently reported by use of WHO's Adverse Reaction Terminology, which will eventually become a subset of the International Classification of Diseases. Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected adverse drug reactions should be reported. Surveillance methods can detect reactions and prove associations.
Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies. [2018]To quantify the frequency and seriousness of adverse events in non-oncology phase I studies with healthy participants.
Adverse non-drug-related complaints by healthy volunteers in Phase I studies compared to the healthy general population. [2019]Some complaints that are reported as adverse drug reactions by healthy subjects during participation in Phase I studies are common complaints in healthy individuals from the normal population. The objective of this study was to compare the incidence of complaints in a group of 192 healthy volunteers in Phase I studies with a control group of 112 healthy subjects who matched the Phase I group participants in terms of demographic and socioeconomic characteristics, and to investigate the relationship between some psychological factors and the incidence of complaints.
Frequent Adverse Drug Reactions, and Medication Groups under Suspicion. [2023]The adverse drug reaction database of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) contains reports of suspected adverse drug reactions (ADRs) that are spon- taneously submitted by physicians, pharmacists, or patients. The aim of the present study was a descriptive analysis of all of these spontaneous reports.
Detection of populations at risk and problem drugs during drug development and in pharmacotherapy. [2019]Rational drug therapy requires knowledge about the ratio of risk (adverse drug reaction) to benefit (therapeutic efficacy) for all drugs to be used in humans. However, with newly marketed drugs, the risk/benefit ratio is usually not sufficiently known. Safety is often less well defined than efficacy. This is the result of the present mode of drug development. Premarketing studies are conducted in comparatively small, homogenous populations over relatively short time intervals and under standardized conditions. Only after marketing are larger, more diversified populations exposed over prolonged times, often under uncontrolled conditions. Adverse drug reactions (ADRs) are the result of either overdosage, or allergic or idiosyncratic reactions. They can be life-threatening or mild. Some of the ADRs are common (greater than 1:10); others are very rare (less than 1:1000). The overall rate of ADR occurrence in ambulatory and hospitalized patients is high enough to have significant socioeconomic consequences. Some of the risk populations can be suspected a priori: elderly, multimorbid patients and patients with compromised drug elimination who may be overdosed if the regimens are not appropriately modified. Some problem drugs may be recognized if they display one or more of the following characteristics: narrow therapeutic index, steep dose-effect relationship, nonlinear kinetics, variable bioavailability, and pharmacogenetically determined kinetics. Other individuals at risk, however, may not be readily identifiable. They develop allergic and idiosyncratic reactions after drug exposure without exhibiting easily recognizable predisposing factors. In order to determine the number of individuals so affected, and the associated drugs as quickly as possible during the developmental process, specific ADR surveillance measures are taken.(ABSTRACT TRUNCATED AT 250 WORDS)