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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 66
Summary
This trial is testing a new drug called ABBV-903 to see if it is safe and well-tolerated by healthy adults. Researchers want to know how the drug behaves in the body when taken in different doses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 66
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 66
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apparent Terminal Phase Elimination Constant (β)
Area Under the Plasma Concentration-time Curve (AUC)
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
+5 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part 3, Sequence 2Experimental Treatment2 Interventions
Participants in Part 3 will follow Sequence 2.
Group II: Part 3, Sequence 1Experimental Treatment2 Interventions
Participants in Part 3 will follow Sequence 1.
Group III: Part 2, PlaceboExperimental Treatment1 Intervention
Participants will receive multiple ascending doses of placebo in Part 2.
Group IV: Part 2, ABBV-903Experimental Treatment1 Intervention
Participants will receive multiple ascending doses of ABBV-903 in Part 2.
Group V: Part 1, PlaceboExperimental Treatment1 Intervention
Participants will receive a single ascending dose of placebo in Part 1.
Group VI: Part 1, ABBV-903Experimental Treatment1 Intervention
Participants will receive a single ascending dose of ABBV-903 in Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo for ABBV-903
2023
Completed Phase 1
~110
ABBV-903
2023
Completed Phase 1
~140
Itraconazole
2017
Completed Phase 2
~830
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,210 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,696 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of certain types of cancer, except for non-spreading skin cancers or early-stage cervical cancer.You must satisfactorily meet all medical requirements, including a comprehensive medical history evaluation, physical examination, vital signs assessment, laboratory analysis and 12-lead ECG.You have a history of epilepsy or any significant health conditions affecting your heart, breathing, kidneys, liver, digestive system, blood, or mental health. You also have any ongoing medical conditions that are not under control.Your body mass index (BMI) falls between 18.0 to 32 kg/m2.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2, Placebo
- Group 2: Part 1, ABBV-903
- Group 3: Part 2, ABBV-903
- Group 4: Part 3, Sequence 1
- Group 5: Part 1, Placebo
- Group 6: Part 3, Sequence 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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