A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03675581
• Date of registration: 17/09/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
• Scientific title: A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
• Date of first enrolment: November 8, 2018
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03675581
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, France, Germany, Netherlands, Portugal, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age >= 18 years

- A woman of non-child bearing potential, i.e. being postmenopausal1 or permanently
sterilised (e.g. hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or
a woman of childbearing potential correctly and consistently using a highly effective
method of non-hormonal birth control (i.e. IUD or bilateral tubal ligation) together
with barrier methods at least 30 days prior to first administration of Microgynon®
(Visit 2), during the trial and for 3 months after last intake of nintedanib.

- 2013 American College of Rheumatology (ACR) / European League against Rheumatism
(EULAR) classification criteria for Systemic Sclerosis associated Interstitial Lung
Disease (SSc) fulfilled

- SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography
(HRCT); Extent of fibrotic disease in the lung >= 10%

- Forced Vital Capacity (FVC) >= 40% of predicted normal

- Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal

- Further inclusion criteria apply

Exclusion criteria:

- Aspartate Transaminase (AST), Alanine Transaminase (ALT) >1.5 x Upper Level of Normal
(ULN).

- Bilirubin >1.5 x ULN

- Creatinine clearance <30 mL/min

- Clinically relevant anaemia at investigators discretion

- Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second
(FEV1)/Forced Vital Capacity (FVC) <0.7)

- Other clinically significant pulmonary abnormalities

- Significant Pulmonary Hypertension (PH)

- Cardiovascular diseases

- More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring
hospitalization or severe other ulcers

- Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose
anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central
nervous system (CNS) event within last year

- International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by >1.5 x ULN)

- History of thrombo-embolic event within last year

- Previous or planned hematopoietic stem cell transplantation

- Clinical signs of malabsorption or needing parenteral nutrition

- Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)

- Previous treatment with nintedanib or pirfenidone

- Further exclusion criteria apply



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Scleroderma, Systemic

Intervention(s)

Drug: Microgynon

Drug: Nintedanib

Primary Outcome(s)

Maximum Measured Concentration of Ethinylestradiol in Plasma (Cmax) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Maximum Measured Concentration of Levonorgestrel in Plasma (Cmax) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Secondary Outcome(s)

Area Under the Concentration-time Curve of Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Area Under the Concentration-time Curve of Ethinylestradiol in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8) [Time Frame: 35 minutes (min) before and at 30 min, 1 hour (h), 1h 30 min, 2h, 3h, 4h, 6h, 8h, 11h 55 min, 23h 55 min, 47h 55 min after microgynon administration alone or in combination with nintedanib.]

Secondary ID(s)

2018-001177-24

1199-0340

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03675581