A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Lev… (NCT07502417) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
United States16 participantsStarted 2026-03-27
Plain-language summary
The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of ethinyl estradiol and levonorgestrel.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Laboratory values meet the criteria specified in the protocol.
* 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 treatment.
* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
* Use of tobacco- or nicotine-containing products within 3 months (90 days) prior to the first dose of study treatment.
* Participant has prior exposure to ABBV-722 within 90 days prior to the first dose of study treatment.
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
2
Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
3
Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
4
Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
5
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
6
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel
Timeframe: Up to Day 5 in Period 1 and between Days 14-21 in Period 2