ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

Exclusion Criteria

• •Current known HIV-infected partners
• •Current use of anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], NSAIDs, or Pradaxa®)
• •Current use of cytochrome P450 3A (CYP3A) inducer(s) and/or inhibitor(s)
• •Use of systemic immunomodulatory medications within 4 weeks of enrollment
• •Known allergic reaction to components of the study product
• •History of recurrent urticaria
• •Participants whose whole body radiation exposure exceeds 5000 millirem (mRem)/year.
• •Participants who are currently receiving or have been on oral PrEP or PEP in the past month
• •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
• •Significant colorectal symptom(s) as determined by medical history or by participant self-report
• •Active rectal infection, requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts.
• •History of STI within the last 3 months.
• •Use of post-exposure (PEP) or pre-exposure (PrEP) prophylaxis within the last 6 months
• •History of significant gastrointestinal bleeding
• •Use of any rectally administered medications within 4 weeks of enrollment or unwillingness to refrain from use of any rectally administered medications 72 hours prior to any study dosing or biopsy visit
• •Use of any rectally administered products containing nonoxynol-9 (including condoms) or investigational products within 4 weeks of enrollment
• •Significant vaginal symptoms, genital lesions, erythema, edema or any other abnormal physical finding that, in the opinion of the investigator or designee, would contraindicate study participation.
• •Active female genital tract infection, requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, bacterial vaginosis, vaginal candidiasis, trichomonas, genital sores or ulcers, and, if clinically indicated, genital warts.
• •History of significant vaginal bleeding
• •Undiagnosed irregular uterine bleeding
• •Post-menopausal defined as 12 months of amenorrhea
• •Per participant report, abnormalities of the female genital tract, which, in the judgment of the investigator, might increase the risk of the study to the research participant.
• •Per participant report, history of cervical procedures (conization, Loop El electrosurgical Excision procedure (LEEP) procedure, cryosurgery) within the previous 6 months.
• •Per participant report, use of any vaginally administered medications within 4 weeks of enrollment
• •Per participant report, use of any vaginally administered products containing nonoxynol-9 (including condoms) or investigational products within 4 weeks of enrollment
• •Women who are pregnant or breastfeeding
• •Spermicide use within the last 30 days