Healthy Adult Premenopausal Female VolunteersPhase 1NCT02641990
Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects
A Phase 1 study of Healthy Adult Premenopausal Female Volunteers, run by Intarcia Therapeutics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Premenopausal Female Volunteers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2015to Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
QPS/Miami Research Associates
Miami, Florida, 33143
Compass Research
Orlando, Florida, 32806
About this study
Official title: 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
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.
- Being tested
- ITCA 650 20/60 mcg/day, ITCA placebo, ITCA placebo, ITCA 650 20/60 mcg/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITCA 650 20/60 mcg/day, ITCA placeboDrug
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
ITCA placebo, ITCA 650 20/60 mcg/dayDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ITCA 650 20/60 mcg/day, ITCA placebo Receives: Drug: ITCA 650 20/60 mcg/day, ITCA placebo |
| Group 2 | Experimental | ITCA placebo, ITCA 650 20/60 mcg/day Receives: Drug: ITCA placebo, ITCA 650 20/60 mcg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel
Measured: from baseline to 13 weeks
Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel
Measured: from baseline to 13 weeks
Secondary outcomes (2)
Time to maximum steady state plasma concentration (tmax,ss) for ethinyl estradiol and levonorgestrel
Immunogenicity parameters:
- ADA (anti-exenatide antibodies)
Safety parameters:
- Treatment-emergent AEs (TEAEs) including any events local to the placement site, clinical laboratory measurements, ECGs, vital signs and physical examinations.
Measured: baseline to 13 weeks
Apparent plasma clearance at steady-state (CL/Fss) for ethinyl estradiol and levonorgestrel
Measured: baseline to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Premenopausal Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641990
- Sponsor's protocol ID
- ITCA 650-CLP-116
- Status last verified
- Mar 2016
- First submitted
- 18 Dec 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02641990
- Acronym / sponsor ID
- ITCA 650-CLP-116
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ITCA 650 20/60 mcg/day, ITCA placeboITCA 650 20/60 mcg/day, ITCA placebo |
| Group 2 | Experimental | Drug: ITCA placebo, ITCA 650 20/60 mcg/dayITCA placebo, ITCA 650 20/60 mcg/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITCA 650 20/60 mcg/day, ITCA placeboITCA 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 | Drug | Group 1 |
| ITCA placebo, ITCA 650 20/60 mcg/dayITCA 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 | Drug | Group 2 |
Primary outcome
Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel
Time frame: from baseline to 13 weeks
Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel
Time frame: from baseline to 13 weeks
2 secondary outcomes
Time to maximum steady state plasma concentration (tmax,ss) for ethinyl estradiol and levonorgestrel
Time frame: baseline to 13 weeks
Apparent plasma clearance at steady-state (CL/Fss) for ethinyl estradiol and levonorgestrel
Time frame: baseline to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Adult Premenopausal Female Volunteers, run by Intarcia Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel (time frame: from baseline to 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.