A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01458210
• Date of registration: 19/10/2011
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Subjects
• Scientific title: Effect of Dulaglutide (LY2189265) on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
• Date of first enrolment: October 2011
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01458210
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- are females of child-bearing potential, and who are overtly healthy as determined by
medical history and physical examination

- as it is possible that dulaglutide may cause the oral contraceptive (OC) tablet
to be less effective than usual, participants will be required to use 2
additional highly effective methods of contraception from the screening
appointment until 2 months after the poststudy follow-up appointment. Additional
methods of contraception may include the following: a non-hormonal intrauterine
device with spermicide; male or female condom with spermicide; contraceptive
sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide;
sterile sexual partner; or abstinence (subjects reporting abstinence who become
sexually active while on the study must agree to use other additional methods of
contraception). The pregnancy test result must be negative at screening and at
each check-in

- have a body mass index (BMI) of between 18.5 and 30.0 kg/m^2, at screening

- have no clinically significant findings, as determined by the investigator, upon
bimanual pelvic and breast examinations, at screening (provision of previous
gynecological examination documentation may be accepted)

- have clinical laboratory test results within the normal reference range for the
population or investigator site, or results with acceptable deviations that are
judged to be not clinically significant by the investigator

- have venous access sufficient to allow for blood sampling

- are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures and restrictions

- have given written informed consent approved by Lilly and the ethical review board
(ERB) governing the site

Exclusion Criteria:

- are currently enrolled in, have completed or discontinued within the last 30 days
from, a clinical trial involving an investigational product, or are concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study

- have known allergies to Ortho-Cyclen, dulaglutide, or to related compounds or to any
components of either formulation

- are persons who have previously completed or withdrawn from this study or any other
study investigating dulaglutide within 3 months prior to screening or have received
glucagon-like peptides or incretin mimetics in the 3 months prior to screening

- have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of
the investigator, increases the risks associated with participating in the study

- have an abnormal blood pressure (BP) (after at least 5 minutes sitting) that, in the
opinion of the investigator, increases the risks associated with participating in the
study

- have a history or presence of respiratory, hepatic, renal, endocrine, hematological,
or neurological disorders capable of significantly altering the absorption,
metabolism, or elimination of drugs; of constituting a risk when taking the study
medication; or of interfering with the interpretation of data

- have a history or presence of cardiovascular disorder (including myocardial
infarction, cerebrovascular accident, coronary artery disease, venous
thromboembolism, arrhythmia [judged by the investigator to be clinically
significant], or angina) within the last year, have symptoms or signs of congestive
heart failure, or are expected to require coronary artery bypass surgery or
angioplasty

- have a history or presence of pancreatitis (history of chronic pancreatitis or
idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant
esophageal reflux or gall bladder disease, or any gastrointestinal disease which
impacts gastric emptying (GE) (e.g. gastric bypass surgery, pyloric stenosis, with
the exception of appendectomy) or could be aggravated by glucagon-like-peptide 1
(GLP-1) analogs. Subjects with dyslipidemia, and subjects who had cholecystolithiasis
(removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the
past, with no further sequelae, may be included in the study at the discretion of the
screening physician

- show evidence of significant active neuropsychiatric disease

- have family history of medullary thyroid cancer (MTC) or a genetic condition that
predisposes to MTC

- regularly use known drugs of abuse and/or show positive findings on urinary drug
screening

- show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV
antibodies.

- show evidence of hepatitis C and/or positive hepatitis C antibody.

- show evidence of hepatitis B and/or positive hepatitis B surface antigen.

- are women with a positive pregnancy test or women who are lactating.

- have used or intend to use St John's Wort within 21 days of study drug administration
or are unable/unwilling to adhere to the study drug restrictions

- have donated blood of more than 500 mL within the last month prior to admission of
the lead-in phase

- have an average weekly alcohol intake that exceeds 14 units per week, or are
unwilling to stop alcohol consumption for 48 hours prior to each admission to the
clinical research unit (CRU) and while resident at the CRU (1 unit = 12 oz or 360 mL
of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

- use of any tobacco- or nicotine-containing products (including but not limited to
cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or
nicotine gum) within 6 months prior to admission into the lead-in phase

- have taken injectable contraceptives or have used hormonal implants within 12 months
of enrollment to this study or topical controlled delivery contraceptives (patch) or
hormonal intrauterine devices (e.g. Mirena® device) within 3 months prior to
enrollment of this study

- the history or presence of any contraindications to the combined OC tablet including
thrombosis and a history of thromboembolic disease, recurrent jaundice, acute or
chronic liver disease, migraines, undiagnosed vaginal bleeding, significant
hyperlipidemia, hepatic adenoma, and mammary, endometrial, or hepatic carcinoma or
any other estrogen-dependent neoplasia (known or suspected)

- in the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Biological: Dulaglutide

Drug: Ortho-Cyclen

Primary Outcome(s)

Pharmacokinetics : Area under the concentration versus time curve (AUC), of Ortho-Cyclen [Time Frame: Day 21 Periods 1 and 2 : Pre-dose and up to 24 hours post dose]

Pharmacokinetics : Maximum observed drug concentration (Cmax) of Ortho-Cyclen [Time Frame: Day 21 Periods 1 and 2 : Pre-dose and up to 24 hours post dose]

Pharmacokinetics : Time of maximum observed drug concentration (tmax) of Ortho-Cyclen [Time Frame: Day 21 Periods 1 and 2 : Pre-dose and up to 24 hours post dose]

Secondary ID(s)

11555

H9X-MC-GBCQ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors