DelfaGLP-1 Atlas

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CompletedPhase 1

Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Crossover Study to Assess the Effect of ITCA 650 on the Pharmacokinetics and Pharmacodynamics of a Combination Oral Contraceptive in Healthy Premenopausal Female Subjects

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

28

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 19-32•Female

Primary endpoints

•AUC at steady state (AUCss) for ethinyl estradiol and levonorgestrel•Plasma concentration (steady state) (Cmax)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02641990
Org study IDITCA 650-CLP-116

Timeline

Milestones

Study first posted2015-12-30estimated
Last update posted2016-03-22estimated
Study start2015-12 (month precision)
Primary completion2016-02actual (month precision)
Study completion2016-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

•Women of childbearing potential.
•Use of a combination oral contraceptive ≥3 months immediately prior to screening.
•Willing to use an additional adequate method of contraception during the study and until 1 additional menstrual cycle following the end-of-study (EOS) visit. Adequate methods of contraception for women of child bearing potential (WOCBP) include: mechanical products (ie, intrauterine device [IUD]-copper IUD); or barrier methods (eg, diaphragm, condoms, cervical cap) with spermicide.
•Body mass index (BMI) ≥19 and ≤32 kg per meter squared.
•Weight ≥50 and ≤100 kg.
•Non-smoker or ex-smoker for >6 months prior to screening (and has stopped using other nicotine products ≥2 weeks prior to screening).

Exclusion criteria

•History of type 1 or type 2 diabetes.
•Received implanted contraceptives within 6 months prior to screening or injected contraceptives within 12 months prior to screening.
•History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
•History of uncontrolled hypertension.
•History or evidence of acute or chronic pancreatitis.
•History of liver disease.
•History of medullary thyroid cancer or a personal or family history of multiple endocrine neoplasia type 2.
•Poor thyroid, liver, or renal function.
•Weight loss surgery or requires weight loss medications.
•History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). (Subjects who have been disease free for 5 years may be included.)
•Estrogen-dependent growths; undiagnosed vaginal bleeding.
•History of active alcohol or substance abuse.
•Regular daily consumption of more than 12 g of alcohol in any form.
•Excessive in xanthine consumption (more than 5 cups of coffee or equivalent per day).
•Treatment with medications that affect GI motility.
•Any condition that would affect drug transit time or absorption (eg, gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, chronic diarrhea, vagotomy, chronic gastroesophageal reflux disease, malabsorption, colostomy, Crohn's disease, ulcerative colitis, or celiac sprue).
•History of hypersensitivity to exenatide.
•Contraindications or warnings according to the specific label(s) for EE and/or LNG therapy.
•Women that are pregnant, lactating, or planning to become pregnant.
•Any use of anticoagulants with the exception of those given in prophylaxis prior to surgical intervention.
•History of or positive results on screening tests for hepatitis B and/or hepatitis C and/or human immunodeficiency virus (HIV).
•Recent surgery or planned in-patient surgery, dental procedure, or hospitalization during the study.
•History of migraine if aged >35 years or has focal symptoms associated with migraine.
•History of thrombophlebitis, thromboembolic disorders, or deep vein thrombophlebitis.
•Fasting triglycerides above upper limit of normal at Screening.
•Any gastrointestinal complaints within 7 days prior to first dosing.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Other (unclassified)
2
Other clinical outcomes
1

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel

Time frame:from baseline to 13 weeks

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel

Time frame:from baseline to 13 weeks

Plasma concentration (steady state)

concentration, descriptive

componentsCmax

Secondary/protocol endpoint

Time to maximum steady state plasma concentration (tmax,ss) for ethinyl estradiol and levonorgestrel

Time frame:baseline to 13 weeks

Tmax

concentration, descriptive

Secondary/protocol endpoint

Apparent plasma clearance at steady-state (CL/Fss) for ethinyl estradiol and levonorgestrel

Time frame:baseline to 13 weeks

descriptive

Other clinical outcomes

1 endpoint
Other/protocol endpoint/low confidence

Additional Outcome Measure 2

Time frame:13 weeks

descriptive

Other (unclassified)

2 endpoints
Other/protocol endpoint/low confidence

Additional Outcome Measure 1

Time frame:13 weeks

descriptive

Other/protocol endpoint/low confidence

Additional Outcome Measure 3

Time frame:13 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.