Drug-drug Interaction Study of CTP-543 and Oral Contracep... | NCT04309643

NCT04309643

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Celerion	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTP-543	Experimental	In Period 1, participants will receive a single oral dose of the combination oral contraceptive (OC) on Day 1. There will be a washout period of 7 days between dosing in Period 1 and the first dose in Period 2. In Period 2, participants will receive twice daily oral doses of CTP-543 for 8 consecutive days with a single dose of the combination OC co-administered on Day 4.	Drug: CTP-543 Drug: Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

Name	Type	Description	Arm Group Labels	Other Names
CTP-543	Drug	Investigational Drug	CTP-543
Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC0-t	Area Under the Plasma Concentration-Time Profile	From the start of Period 1 to completion of Period 2 (16 days)
AUC0-inf	Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time	From the start of Period 1 to completion of Period 2 (16 days)
Cmax	Maximum observed concentration of drug in plasma	From the start of Period 1 to completion of Period 2 (16 days)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention	Up to 58 days
Number of Participants With Clinically Significant Change in Vital Signs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy female participants of non-childbearing potential, or adult females of childbearing potential who agree to use birth control methods described in the protocol
If of reproductive age, willing and able to use a medically highly effective form of birth control 28 days prior to first dose, during the study and for 28 days following last dose of study medication. Examples of medically highly effective forms of birth control are:
1. Surgical sterilization of the partner (via vasectomy, hysterectomy, bilateral tubal ligation or bilateral salpingectomy) at least 4 months prior to first dose or post-menopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels (> 40 IU/L) consistent with postmenopausal status
2. Sexual partner is sterile, or of the same sex
3. Double-barrier method (any combination of physical and chemical methods)
4. Non-hormone releasing intrauterine device in females
Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
Medically healthy with no clinically significant medical history, physical examination, laboratory tests, vital signs, or ECGs
Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

Positive pregnancy test
History or presence of clinically significant medical or psychiatric condition or disease
History of any illness that might confound the results of the study or pose an additional risk to the subject by their participation in the study
History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
A positive tuberculosis test at screening or history of incompletely treated or untreated tuberculosis
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
Donation of blood or significant blood loss within 56 days prior to dosing