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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 & 2 | Experimental | In Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinyl Estradiol + Levonorgestrel | Drug | Oral |
| |
| ABBV-722 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel | Cmax of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel | Tmax of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel | β of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel | t1/2 of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel | AUCt of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel | AUCinf of Ethinyl Estradiol and Levonorgestrel. | Up to Day 5 in Period 1 and between Days 14-21 in Period 2 |
| Number of Participants with Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 281745 | Grayslake | Illinois | 60030 | United States |
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| Drug |
Oral |
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
| Up to Approximately 82 Days |
| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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