A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension (SALTO)

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged >=2 to <18 Years With Pulmonary Arterial Hypertension

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Drug: Selexipag; Drug: Placebo; Drug: Standard of Care (SOC): Endothelin receptor antagonist; Drug: SOC: Phosphodiesterase type 5 (PDE-5) inhibitor; Drug: SOC: Soluble guanylate cyclase stimulator

Detailed Description

Pediatric PAH is a rare and progressive disorder associated with considerable morbidity and mortality. Given the significant medical need to develop treatments in children with PAH, further clinical studies in the pediatric population are therefore needed to provide more data for the management of PAH in children. Selexipag (JNJ-67896049) is an orally available, selective, and long-acting non-prostanoid agonist of the prostacyclin receptor approved and commercially available for the treatment of adult participants with PAH. Selexipag and its metabolite possess anti-fibrotic, anti-proliferative, and anti-thrombotic properties. Currently, no medicines targeting prostacyclin pathway are approved for pediatric use in PAH. An effective and orally available therapy acting on the prostacyclin receptor such as selexipag introduced at medically appropriate stage of PAH disease, and primarily in combination with current first-line oral PAH-specific medicines in participants in need of additional therapy because of insufficient disease control would represents a major advance to the therapeutic management of PAH pediatric participants. This study consists of a screening period of up to 6 weeks and a double-blind treatment period, including up-titration and maintenance periods, followed by a 3-year open-label extension period (OLEP) and a 30-day safety follow-up period that occurs after the last dose of study intervention (either double-blind or open-label). Safety, pharmacokinetic and efficacy assessments will be performed during the study. An Independent Data Monitoring Committee (IDMC) will be established to monitor data on an ongoing basis, to review interim data, and to ensure the continuing safety of the participants enrolled in this study. The approximate duration of the study is 8 years.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Brisbane, Australia, 4101
    • Queensland Children's Hospital
• Belarus
  • Minsk, Belarus, 220013
    • State Institution Republican Scientific And Practical Center For Pediatric Surgery
  • Minsk, Belarus, 220118
    • Health Institution 4Th City Children'S Clinical Hospital
• Belgium
  • Brussels, Belgium, 1070
    • ULB Hopital Erasme
  • Ghent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
• Brazil
  • Blumenau, Brazil, 89030-101
    • Complexo de Prevencao,Diagnostico,Terapia e Reabilitacao Respiratoria LTDA Hospital Dia do Pulmao
  • Brasília, Brazil, 70310-500
    • Fundacao Universitaria de Cardiologia - Instituto de Cardiologia e Transplantes do DF
  • Curitiba, Brazil, 80250-060
    • Hospital Pequeno Príncipe
  • Fortaleza, Brazil, 60840-285
    • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Porto Alegre, Brazil, 90020-090
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90620-001
    • Fundacao Universitaria de Cardiologia
  • São Paulo, Brazil, 01221-020
    • Irmandade Santa Casa de Misericordia de Sao Paulo
  • São Paulo, Brazil, 04024 002
    • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
• Bulgaria
  • Sofia, Bulgaria, 1309
    • Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital
  • Guangzhou, China, 510623
    • Guangzhou Women and Children's Medical Center
  • Qingdao, China, 266000
    • Qingdao Women and Children's Hospital
  • Qingdao, China, 266000
    • Qingdao Women and Children's Hospital 1
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University
  • Shanghai, China, 200127
    • Shanghai Childrens Medical Center
  • Shenyang, China, 110000
    • The General Hospital of Northern Theater Command
• Colombia
  • Bogotá, Colombia
    • Fundacion Santa Fe de Bogota
  • Bogotá, Colombia, 0000000
    • Clinica San Rafael
  • Bogotá, Colombia, 0000000
    • Fundación Neumologica Colombiana
  • Cali, Colombia, 760042
    • Clínica Imbanaco S.A.S.
  • Piedecuesta, Colombia, 681017
    • Fundacion cardiovascular de Colombia
  • Soledad, Colombia, 0000000
    • Hospital Universidad del Norte
• Finland
  • Helsinki, Finland, 29
    • New Children's Hospital of the Helsinki University Hospital (HUS)
• France
  • Lille, France, 59037
    • Hôpital Cardiologique - Chru Lille
  • Marseille, France, 13385
    • Hopital de La Timone
  • Montpellier, France, 34295
    • CHU Arnaud de Villeneuve
  • Paris, France, 75015
    • Hôpital Necker - Enfants Malades
  • Pessac, France, 33604
    • Hôpital Cardiologique Du Haut-Lévêque
  • Toulouse, France, 31059
    • Chu Hopital Des Enfants
• Germany
  • Freiburg im Breisgau, Germany, 70106
    • Universitätsklinikum Freiburg Zentrum
  • Heidelberg, Germany, D-69120
    • Universitaetsklinikum Heidelberg
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • München, Germany, 81377
    • Klinikum der Universitaet Muenchen
• Hungary
  • Budapest, Hungary, 1096
    • Gottsegen György Országos Kardiológiai Intézet
• Ireland
  • Dublin, Ireland
    • Our Lady's Children's Hospital
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Padova, Italy
    • Universta Degli Studi Di Padova
  • Roma, Italy, 00193
    • Ospedale Pediatrico Bambin Gesù
  • S. Donato Milanese, Italy, 20097
    • IRCCS Policlinico San Donato
  • Torino, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita
• Lithuania
  • Vilnius, Lithuania, LT08661
    • Vilnius University Hospital Santariskiu Clinics
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • National Heart Institute
• Mexico
  • Guadalajara, Mexico, 44160
    • CICUM San Miguel
  • Monterrey, Mexico, 64718
    • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
  • México, Mexico, 52787
    • Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
• Poland
  • Gdansk, Poland, 80 952
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 30-663
    • Uniwersytecki Szpital Dziecięcy w Krakowie
  • Poznan, Poland, 60 572
    • Szpital Kliniczny im Karola Jonschera
  • Warsaw, Poland, 04-730
    • Instytut Pomnik Centrum Zdrowia Dziecka
  • Wroclaw, Poland, 51 124
    • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • Zabrze, Poland, 41-800
    • Slaskie Centrum Chorob Serca
• Portugal
  • Lisbon, Portugal, 1169-024
    • Uls Sao Jose - Hosp. Santa Marta
  • Porto, Portugal, 4200 319
    • Uls Sao Joao - Hosp. Sao Joao
• Russia
  • Kazan', Russia, 420012
    • Kazan State Medical University
  • Kazan', Russia, 420059
    • Kazan State Medical University 1
  • Kemerovo, Russia, 650002
    • Scientific and Research Institution of Cardiovascular Diseases Complex Problems
  • Moscow, Russia, 125373
    • Childrens City Clinical Hospital n.a. Bashlyaeva
  • Moscow, Russia, 125412
    • Veltischev Research and Clinical Institute for Pediatrics of the Pirogov RNRMU
  • Samara, Russia, 443070
    • Samara Regional Clinical Cardiological Dispensary
• Serbia
  • Belgrade, Serbia, 11000
    • Univerzitetska Dečja Klinika
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 120-752
    • Severance Hospital Yonsei University Health System
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hosp Univ A Coruna
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • Esplugues de Llobregat, Spain, 08950
    • Hosp. Sant Joan de Deu
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28009
    • Hosp. Gral. Univ. Gregorio Maranon
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
• Sweden
  • Gothenburg, Sweden, 416 50
    • Drottning Silvias barn- och ungdomssjukhus
  • Lund, Sweden, 222 42
    • Skanes Universitetssjukhus
• Switzerland
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois CHUV
• Taiwan
  • Kaohsiung City, Taiwan, 813414
    • Kaohsiung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• Thailand
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University Hospital
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01790
    • Cukurova Balcali Hospital Application and Research Center
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34093
    • CAPA Istanbul University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34303
    • Mehmet Akif Ersoy Training and Research Hospital
  • Izmir, Turkey (Türkiye), 35020
    • Izmir Tepecik Training and Research Hospital
  • Izmir, Turkey (Türkiye), 35210
    • Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
• Ukraine
  • Dnipro, Ukraine, 49006
    • Dnipropetrovsk clinical medical center of Mother and Child after prof. Rudnev
  • Dnipro, Ukraine, 49070
    • MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
  • Kyiv, Ukraine, 04050
    • Scientific Practical Medical Center for Pediatric Cardiology and Cardio Surgery of the MOH
  • Zaporizhzhya, Ukraine, 69063
    • MI Zaporizhzhia Regional Clinical Childrens Hospital of Zaporizhzhia Regional Council
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • San Francisco, California, United States, 94158
      • UCSF
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • Congenital Heart Center of the University of Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Childrens Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Division of Pediatric Cardiology
• Vietnam
  • Hanoi, Vietnam
    • Hanoi Medical University Hospital
  • Ho Chi Minh City, Vietnam, 700000
    • University Medical Center Ho Chi Minh city
  • Ho Chi Minh City, Vietnam
    • Children's Hospital 1
  • Ho Chi Minh City, Vietnam, 700000
    • Tam Anh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants between greater than or equal to (>=) 2 and less than (<) 18 years of age weighing >=9 kilogram (kg) at randomization
• Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's screening
• PAH (World Health Organization [WHO] Group 1), including participants with Down syndrome, of the following etiologies: Idiopathic PAH (IPAH); Heritable PAH (HPAH); PAH associated with congenital heart disease (PAH-associated with congenital heart disease [aCHD]) (PAH with coincidental CHD [that is, a small atrial septal defect, ventricular septal defect, or patent ductus arteriosus that does not itself account for the development of elevated PVR] and if approved by the BCAC) and Post-operative PAH (persisting / recurring/ developing >=6 months after repair of CHD); Drug or toxin-induced; PAH associated with Human immunodeficiency virus (HIV)
• WHO functional class (FC) II and III
• Participants treated with at least 1 PAH-specific treatment, example, an Endothelin receptor antagonist (ERA) and/or a Phosphodiesterase type-5 (PDE-5) inhibitor/soluble guanylate cyclase stimulator, provided that the treatment dose(s) has been stable for at least 3 months prior to first dose of study intervention

Exclusion Criteria:

• PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis
• PAH associated with Eisenmenger syndrome
• Previous exposure to Uptravi (selexipag)
• Known concomitant life-threatening disease with a life expectancy <12 months
• Pregnant, planning to become pregnant, or lactating
• Known allergies, hypersensitivity, or intolerance to selexipag or its excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selexipag; Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose. Participants will continue to receive pulmonary arterial hypertension (PAH)-specific concomitant therapies such as ERAs, PDE-5 inhibitors, and soluble guanylate cyclase stimulator as per local standard-of-care.	Drug: Selexipag; Selexipag tablet will be administered orally.; Other Names: JNJ-67896049; Drug: Standard of Care (SOC): Endothelin receptor antagonist; ERAs will be administered as SOC therapy.; Drug: SOC: Phosphodiesterase type 5 (PDE-5) inhibitor; PDE-5 inhibitor will be administered as SOC therapy.; Drug: SOC: Soluble guanylate cyclase stimulator; Soluble guanylate cyclase stimulator will be administered as SOC therapy.
Placebo Comparator: Placebo; Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Participants will continue to receive PAH-specific concomitant therapies such as ERAs, PDE-5 inhibitors, and soluble guanylate cyclase stimulator as per local standard-of-care.	Drug: Placebo; Matching placebo tablets will be administered orally.; Drug: Standard of Care (SOC): Endothelin receptor antagonist; ERAs will be administered as SOC therapy.; Drug: SOC: Phosphodiesterase type 5 (PDE-5) inhibitor; PDE-5 inhibitor will be administered as SOC therapy.; Drug: SOC: Soluble guanylate cyclase stimulator; Soluble guanylate cyclase stimulator will be administered as SOC therapy.
Experimental: Open-Label Extension Period: Selexipag; Participants with a positive benefit/risk ratio of selexipag for PAH will be offered selexipag in the open label extension period. Participants on selexipag during the double-blind treatment period will continue treatment at their iMTD during the OLEP, for those previously on placebo, the iMTD will uptitrate selexipag during first 12 weeks until participant reaches iMTD. Participants will continue to receive PAH-specific concomitant therapies such as ERAs, PDE-5 inhibitors, and soluble guanylate cyclase stimulator as per local standard-of-care.	Drug: Selexipag; Selexipag tablet will be administered orally.; Other Names: JNJ-67896049; Drug: Standard of Care (SOC): Endothelin receptor antagonist; ERAs will be administered as SOC therapy.; Drug: SOC: Phosphodiesterase type 5 (PDE-5) inhibitor; PDE-5 inhibitor will be administered as SOC therapy.; Drug: SOC: Soluble guanylate cyclase stimulator; Soluble guanylate cyclase stimulator will be administered as SOC therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Disease Progression	Time to disease progression is the time from randomization up to 7 days after study treatment discontinuation. Disease progression is defined as the first occurrence of either of the following components: Death (all causes), Atrial septostomy or Potts' anastomosis, or registration on lung transplant list, Hospitalization due to worsening pulmonary arterial hypertension (PAH), Clinical worsening of PAH.	From randomization up to 7 days after study treatment discontinuation (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious AEs	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs with onset during the intervention period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Up to 5 years
Percentage of Participants with AEs Leading to Premature Discontinuation of Study Treatment	Percentage of participants with AEs leading to premature discontinuation of study treatment will be reported.	Up to 5 years
Change from Baseline in Systolic and Diastolic Arterial Blood Pressure	Change from baseline in systolic and diastolic arterial blood pressure to all assessed time points will be reported.	Baseline up to end of treatment (EOT) (up to 8 years)
Change from Baseline in Pulse Rate	Change from baseline in pulse rate to all assessed time points will be reported.	Baseline up to EOT (up to 8 years)
Change from Baseline in Body Weight	Change from baseline in body weight to all assessed time points will be reported.	Baseline up to EOT (up to 8 years)
Change from Baseline in Height	Change from baseline in height to all assessed time points will be reported.	Baseline up to EOT (up to 8 years)
Sexual Maturation (Tanner Stage) Change from Baseline to all Assessed Time Points	The sexual maturation change as per Tanner stage will be assessed from baseline to all assessed time points. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs.	Up to 3 days after study treatment discontinuation (up to EOT) (multiple timepoints up to 8 years)
Percentage of Participants with Treatment-emergent Electrocardiogram Abnormalities	Percentage of participants with treatment-emergent electrocardiogram abnormalities will be reported.	Baseline up to EOT (up to 8 years)
Percentage of Participants with Treatment-emergent Marked Laboratory Abnormalities	Percentage of participants with treatment-emergent marked laboratory (serum chemistry [including pregnancy testing and thyroid markers] and hematology) abnormalities will be reported.	Baseline up to EOT (up to 8 years)
Treatment-emergent Change from Baseline in Thyroid Stimulating Hormone	Treatment-emergent change from baseline in thyroid stimulating hormone over time will be reported.	Baseline up to EOT (up to 8 years)
Trough Plasma Concentration at Steady-state (Ctrough,ss) of Selexipag and its Metabolite ACT-333679	Ctrough,ss is defined as the plasma concentration just prior to the morning dose, with the last study intervention administration one day prior to the pharmacokinetic sampling and will be reported for Selexipag and its metabolite ACT-333679.	Weeks 16, 24 and every 12 weeks thereafter (up to 8 years)
Time to First Clinical Event Committee (CEC)-confirmed Hospitalization or Death for PAH	Time to first CEC-confirmed hospitalization or death for PAH is the time (days) from randomization to first occurrence of CEC-confirmed hospitalization for PAH or death due to PAH up to 7 days after study intervention discontinuation.	Until 7 days after study treatment discontinuation (Up to 8 years)
Change from Baseline at Week 24 in Log2 N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	The change from baseline at week 24 in log2 NT-proBNP will be reported.	Baseline up to Week 24

Collaborators and Investigators

• Sponsor: Actelion
• Investigators: Study Director: Actelion Clinical Trial, Actelion

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): October 11, 2024
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; selexipag; PDE5A protein, human
• Other Study ID Numbers: CR108716; 2019-002817-21 (EudraCT Number); AC-065A310 (Other Identifier: Janssen Research & Development, LLC); 2022-501012-34-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No