A Phase 1 interventional study of ABBV-903 and Placebo for ABBV-903 in Healthy Volunteer, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single ascending dose of ABBV-903 in Part 1.
Drug: ABBV-903
Participants will receive a single ascending dose of placebo in Part 1.
Drug: Placebo for ABBV-903
Participants will receive multiple ascending doses of ABBV-903 in Part 2.
Drug: ABBV-903
Participants will receive multiple ascending doses of placebo in Part 2.
Drug: Placebo for ABBV-903
Participants in Part 3 will follow Sequence 1.
Drug: ABBV-903 · Drug: Itraconazole
Participants in Part 3 will follow Sequence 2.
Drug: ABBV-903 · Drug: Itraconazole
Capsule; oral
Capsule; oral
Capsule; oral
Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Time frame: Baseline to Day 36
Time to Cmax (Tmax)
Tmax will be assessed.
Time frame: Baseline to Day 36
Apparent Terminal Phase Elimination Constant (β)
Apparent terminal phase elimination constant (β) will be assessed.
Time frame: Baseline to Day 36
Terminal Phase Elimination Half-life (t1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Time frame: Baseline to Day 36
Area Under the Plasma Concentration-time Curve (AUC)
AUC will be assessed.
Time frame: Baseline to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)
AUCt will be assessed.
Time frame: Baseline to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
AUCinf will be assessed.
Time frame: Baseline to Day 36
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.
Time frame: Baseline to Day 66
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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