Suzetrigine for Oral Contraceptive Interaction

This trial tests how the medication Suzetrigine affects the function of oral contraceptives (birth control pills) in the body. Participants will take Suzetrigine along with either Norgestimate/Ethinyl Estradiol or Drospirenone/Ethinyl Estradiol, both common birth control pills. The trial aims to determine if Suzetrigine alters the effectiveness of these contraceptives. This study suits non-smokers or those who quit smoking over a year ago, have a body mass index (BMI) between 18 and 30, and weigh more than 50 kilograms (about 110 pounds). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new medication.

The trial information does not specify if you need to stop taking your current medications. However, if you have conditions that affect how drugs are absorbed or processed in your body, you might not be eligible to participate.

Research has shown that suzetrigine, when used with birth control pills, has generally been well-tolerated in past studies. Some evidence indicates that suzetrigine did not cause significant changes in the levels of hormones like ethinyl estradiol or levonorgestrel, which are found in these contraceptives. This suggests a lower risk of unexpected side effects from changes in hormone levels.

However, suzetrigine can interact with other drugs and may cause side effects if taken with strong inhibitors that affect its processing in the body. Participants should inform their doctor about all medications they are taking to avoid these interactions.

Researchers are excited about suzetrigine because it potentially offers a novel way to interact with oral contraceptives like Norgestimate/Ethinyl Estradiol (NGM/EE) and Drospirenone/Ethinyl Estradiol (DRSP/EE). Unlike standard hormonal contraceptives, which primarily work by preventing ovulation, suzetrigine might be capable of influencing how these contraceptives are metabolized in the body. This could lead to more effective or consistent contraceptive performance. Additionally, the unique dosing schedule of suzetrigine, administered every 12 hours, may provide a more consistent therapeutic effect, addressing gaps that current options might leave open.

This trial will evaluate the interaction of Suzetrigine with different oral contraceptives. Studies have shown that Suzetrigine does not significantly affect the efficacy of birth control pills. Research indicates that Suzetrigine does not alter the levels of ethinyl estradiol, a key hormone in many birth control pills, ensuring they continue to work as expected. Additionally, no significant changes were observed in how the body processed other hormones like levonorgestrel. Overall, evidence suggests that taking Suzetrigine with birth control pills should not impact their ability to prevent pregnancy. Participants in this trial will receive Suzetrigine alongside either Norgestimate/Ethinyl Estradiol or Drospirenone/Ethinyl Estradiol to further assess these interactions.⁵⁶⁷⁸⁹