A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults

Healthy Volunteer Clinical Trial

Official title:

A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691699
• Other study ID #: M24-112
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2023
• Est. completion date: October 23, 2023

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at Screening and upon initial confinement.

• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ABBV-903
Capsule; oral
• Placebo for ABBV-903
Capsule; oral
• Itraconazole
Capsule; oral

Locations

Country	Name	City	State
United States	Acpru /Id# 251279	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Cmax will be assessed.	Baseline to Day 36
Primary	Time to Cmax (Tmax)	Tmax will be assessed.	Baseline to Day 36
Primary	Apparent Terminal Phase Elimination Constant (ß)	Apparent terminal phase elimination constant (ß) will be assessed.	Baseline to Day 36
Primary	Terminal Phase Elimination Half-life (t1/2)	Terminal phase elimination half-life (t1/2) will be assessed.	Baseline to Day 36
Primary	Area Under the Plasma Concentration-time Curve (AUC)	AUC will be assessed.	Baseline to Day 36
Primary	Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)	AUCt will be assessed.	Baseline to Day 36
Primary	Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)	AUCinf will be assessed.	Baseline to Day 36
Primary	Number of Participants with Adverse Events (AEs)	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.	Baseline to Day 66

External Links

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