Clinical trials: sponsored by Ipsen
Hepatic Impairment, Healthy
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy…
- Trial name
- NCT06908954
- Testing
- Palovarotene
- Where
- 4 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy Volunteers
Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor…
- Trial name
- NCT05543369
- Testing
- Elafibranor
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy Participants
A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).
- Trial name
- NCT05564208
- Testing
- elafibranor
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy Participants
A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants
Study aimed at comparing the pharmacodynamic profile (including duration of action) of three commercialized toxins by measuring the action potential of the injected muscle (extensor digitorum brevis)
- Trial name
- NCT04970407
- Testing
- Botulinum toxin type A
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy Volunteers
Study of A4250 in Healthy Volunteers Under Fasting, Fed and Sprinkled Conditions
The primary objective of this study is to determine the single-dose pharmacokinetics (PK) of A4250 when administered after a high-fat meal and when sprinkled on applesauce in healthy adult subjects.
- Trial name
- NCT03608319
- Testing
- A4250
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Albireo
Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects.
- Conditions
- Orphan Cholestatic Liver Diseases, Primary Biliary Cirrhosis, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
- Trial name
- NCT02963077
- Testing
- A4250, CRC (A3384), Questran
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Albireo
Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis
An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural…
- Conditions
- Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Primary Biliary Cirrhosis
- Trial name
- NCT03082937
- Testing
- 3 mg [14C]-A4250 capsule
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Albireo
Spasticity
Retrospective Real-Life Study From One Brazilian Reference Center Assessing Long-Term Experience In The Treatment Of Adult Spasticity With AbobotulinumtoxinA
The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum…
- Trial name
- RETURN (NCT04446702)
- Where
- Brazil
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ipsen
Gastroenteropancreatic Neuroendocrine Tumors
Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs
This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut…
- Trial name
- EXPLAIN (NCT02630654)
- Testing
- This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.
- Where
- 25 sites in Denmark, Estonia and 5 more
- Volunteers
- 404 people, healthy volunteers welcome
- Sponsor
- Ipsen
Fibrodysplasia Ossificans Progressiva
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of…
- Trial name
- NCT04829773
- Testing
- Palovarotene, midazolam
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
FOP
Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian subjects aged 18 to 55 years.
- Trial name
- NCT04829786
- Testing
- palovarotene low-dose, palovarotene high-dose
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
Dry Eye Disease
Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects
Dry eye disease (DED) is a keratoconjunctive disorder that "is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage…
- Trial name
- NCT04762355
- Testing
- Palovarotene, Vehicle
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
Renal Impairment
Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function
Renal excretion is a minor elimination route of telotristat etiprate. So this trial is intended to assess the drug behaviour in subjects with decreased renal function.
- Trial name
- NCT03442725
- Testing
- Telotristat etiprate
- Where
- 4 sites in Belgium, Germany and 2 more
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Ipsen
Diagnosis Disease
Efficacy, Safety and Tolerability of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy
The purpose is to demonstrate that BLI800 is non-inferior, on overall colon cleansing, to Fortrans® (a reference colonic lavage in China) administered in adult subjects scheduled to undergo a colonoscopy for a routinely accepted…
- Trial name
- EASY (NCT03562884)
- Testing
- BLI800, Fortrans®
- Where
- 10 sites in China
- Volunteers
- 297 people, healthy volunteers welcome
- Sponsor
- Ipsen
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
IGF-1 Deficiency
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population
To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric…
- Trial name
- EDISON (NCT01676090)
- Where
- 9 sites in Spain
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Ipsen