Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)
研究概览
简要总结
The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy females as determined by medical history, physical examination, and other screening procedures
- •Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening
- •Are not intending to start a family within 2 months after the study
排除标准
- •Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds
- •Have a medical condition or medical history that precludes the taking of combined oral contraceptives
- •Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
- •Have used hormonal implants or received hormonal injections in the past 12 months
- •Unwilling to comply with smoking restrictions during the study
- •Is a known user of drugs of abuse
研究组 & 干预措施
Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)
Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.
干预措施: EE/NGM (Drug)
EE/NGM + Tirzepatide (Period 2)
Participants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC).
干预措施: Tirzepatide (Drug)
EE/NGM + Tirzepatide (Period 2)
Participants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC).
干预措施: EE/NGM (Drug)
结局指标
主要结局
Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)
时间窗: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Norelgestromin (NGMN)
Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)
时间窗: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Cmax of Norelgestromin (NGMN)
Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE
时间窗: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
PK: Cmax of EE
Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)
时间窗: Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\[0-tau\]) of Ethinylestradiol (EE)
次要结局
未报告次要终点