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A Study to Assess the Adverse Events and How Oral ABBV-1606 Moves Through the Body of Healthy Adult Participants.
A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1606 in Healthy Adult Subjects
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1606 moves through the body of healthy adult participants.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
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Illinois
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Grayslake, Illinois, Verenigde Staten, 60030
- Acpru /Id# 277795
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Total body weight > 50.0 kg at Screening.
- A condition of general good health, based upon the results of a medical history, physical examination, neurological examination, vital signs, laboratory profile, and a 12-lead ECG.
Exclusion Criteria:
- History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, immunological, neurological, pulmonary, metabolic, endocrine or psychiatric disease or disorder, active or chronic infectious diseases or any uncontrolled medical illness.
- History of any vasculitis-related conditions, or any confirmed autoimmune or connective tissue diseases (e.g., Systemic Lupus Erythematosus, Sjogren's Syndrome, inflammatory bowel disease, etc.) as per the Investigator judgement.
- History of unexplained purpura or skin rash, or unexplained signs or symptoms suggestive of vasculitis (including, but not limited to, fever, weight loss, arthralgia or arthritis, myalgia, hematuria, abdominal pain, gastrointestinal bleeding, etc.) that is not resolved for at least 30 days prior to dosing.
- History of any abnormal result for Antinuclear antibody (ANA) or Antineutrophil cytoplasmic antibody (ANCA) at Screening
- Abnormal result for C-Reactive Protein (CRP) or Erythrocyte Sedimentation Rate (ESR), or fibrinogen > the Upper limit of normal (ULN) at Screening.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ABBV-1606 or Placebo Group 1
Participants will receive a single oral dose of ABBV-1606 or placebo group 1 on day 1. |
Oral Solution Oral Solution |
|
Experimenteel: ABBV-1606 or Placebo Group 2
Participants will receive a single oral dose of ABBV-1606 or placebo group 2 on day 1. |
Oral Solution Oral Solution |
|
Experimenteel: ABBV-1606 or Placebo Group 3
Participants will receive a single oral dose of ABBV-1606 or placebo group 3 on day 1. |
Oral Solution Oral Solution |
|
Experimenteel: ABBV-1606 or Placebo Group 4
Participants will receive a single oral dose of ABBV-1606 or placebo group 4 on day 1. |
Oral Solution Oral Solution |
|
Experimenteel: ABBV-1606 or Placebo Group 5
Participants will receive a single oral dose of ABBV-1606 or placebo group 5 on day 1. |
Oral Solution Oral Solution |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants Experiencing Adverse Events
Tijdsspanne: Up to approximately 35 days
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment |
Up to approximately 35 days
|
|
Maximum observed plasma concentration (Cmax) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
Cmax of ABBV-1606 |
Up to approximately 5 days
|
|
Time to maximum observed plasma concentration (Cmax) (Tmax) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
Tmax of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
AUCt of ABBV-1606 |
Up to approximately 5 days
|
|
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
AUCinf of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent terminal phase elimination constant (β) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
β of ABBV-1606 |
Up to approximately 5 days
|
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
t1/2 of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent clearance (CL/F) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
CL/F of ABBV-1606 |
Up to approximately 5 days
|
|
Apparent volume of distribution (Vz/F) of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
Vz/F of ABBV-1606 |
Up to approximately 5 days
|
|
Dose Normalized Cmax of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
Dose Normalized Cmax of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
|
Dose Normalized AUC of ABBV-1606
Tijdsspanne: Up to approximately 5 days
|
Dose Normalized AUC of ABBV-1606 will be assessed. |
Up to approximately 5 days
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- M25-822
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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