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

NCT02641990 | Completed Phase 1

• 1 other identifier: ITCA 650-CLP-116
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.

Conditions

Healthy Adult Premenopausal Female Volunteers

Outcome Measures

Primary Outcomes (2)

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

  from baseline to 13 weeks

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

  from baseline to 13 weeks

Secondary Outcomes (2)

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

  baseline to 13 weeks

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

  baseline to 13 weeks

Other Outcomes (3)

• Additional Outcome Measure 1

  13 weeks

• Additional Outcome Measure 2

  13 weeks

• Additional Outcome Measure 3

  13 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

ITCA 650 20/60 mcg/day, ITCA placebo

Drug: ITCA 650 20/60 mcg/day, ITCA placebo

Group 2

EXPERIMENTAL

ITCA placebo, ITCA 650 20/60 mcg/day

Drug: ITCA placebo, ITCA 650 20/60 mcg/day

Interventions

ITCA 650 20/60 mcg/day, ITCA placebo DRUG

ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days

Group 1

ITCA placebo, ITCA 650 20/60 mcg/day DRUG

ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (2)

QPS/Miami Research Associates

Miami, Florida, 33143, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

MeSH Terms

Interventions

Exenatide

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)