Clinical trials: Absorption; Disorder
Psoriasis
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants…
- Trial name
- NCT03987763
- Testing
- IDP-122 Lotion
- Where
- 9 sites in United States, Dominican Republic and 1 more
- Volunteers
- 45 people
- Sponsor
- Bausch Health Americas, Inc.
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Diabetes Mellitus, Type 2
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.
- Trial name
- NCT01366287
- Testing
- PF-03882845
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Mucositis, Pain
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral…
- Conditions
- Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00956254
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- INSYS Therapeutics Inc
Neuropathic Pain
Absorption, Metabolism, and Excretion Study of BIIB074
The primary objectives of the study are: To determine the mass balance and routes of elimination of BIIB074 and its known metabolites following administration of a single oral dose of BIIB074 in healthy male participants and To…
- Trial name
- NCT02751905
- Testing
- BIIB074
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Biogen
Cardiovascular Disease
Absolute Bioavailability and ADME Study of [14C]AZD9977 in Healthy Male Subjects
Study to Assess the Absorption, Metabolism, and Excretion of [14C]AZD9977 after a Single-Dose Oral Administration
- Trial name
- NCT04686591
- Testing
- AZD9977 capsule 50 mg, [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL), [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Cystic Fibrosis, Pancreatic Insufficiency
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan).
- Trial name
- NCT00513682
- Testing
- Ultrase® MT20
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Forest Laboratories
Healthy Volunteers
A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders
This is a randomized, double-blind, three-part, two-sequence per part, two-period, single-dose, cross-over study in healthy male volunteers to compare the PK, safety, and immunogenicity of MB04 and EU /US Enbrel®.
- Trial name
- MB04-A-01-23 (NCT06392074)
- Testing
- MB04, US License Enbrel, EU Source Enbrel
- Where
- Netherlands
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Non-Alcoholic Steatohepatitis
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
- Trial name
- NCT02571192
- Testing
- SHP626, 5.95 μCi RAD
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Safety and Pharmacokinetics in Healthy Volunteer Subjects
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the…
- Trial name
- AME/FE (NCT01611467)
- Testing
- CC-223
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Iron-deficiency
Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules
Open, monocentric, comparative, cross-over study to evaluate the rate and the extent of iron absorption after a single oral dose of (A) IBSA Iron orodispersible film vs (B) SiderAL® FORTE capsules in healthy women aged 18 to 55…
- Trial name
- NCT05660200
- Testing
- IBSA Iron ODF, SiderAL® FORTE
- Where
- Italy
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- IBSA Farmaceutici Italia Srl
Hepatic Insufficiency, Liver Diseases
A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose
This is a research study to understand how liver impairment affects the way the body processes a new cancer medicine called sevabertinib (BAY 2927088).
- Conditions
- Hepatic Insufficiency, Liver Diseases, Pharmacokinetics, Drug Metabolism
- Trial name
- NCT07102095
- Testing
- Sevabertinib
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bayer
Type II Diabetes
Mass Balance and Biotransformation of [14C]HSK7653 in Human
A single-center, single-dose, non-randomized, open-label design.
- Trial name
- NCT04540016
- Testing
- [14C]HSK7653
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Psoriasis
A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis
This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque…
- Trial name
- NCT03988439
- Testing
- IDP-118 Lotion
- Where
- 9 sites in United States, Dominican Republic and 1 more
- Volunteers
- 16 people
- Sponsor
- Bausch Health Americas, Inc.
Secondary Hypogonadism
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in…
- Trial name
- NCT02274181
- Testing
- Androxal
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Healthy Participants, Obesity
A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk Factors
The main purposes of this study are: to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors to determine how quickly and to what…
- Conditions
- Healthy Participants, Obesity, Type 2 Diabetes Mellitus (T2DM)
- Trial name
- NCT07463196
- Testing
- ACI-19764 at dose A1, ACI-19764 at dose A2, ACI-19764 at dose A3
- Where
- Netherlands
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- AC Immune SA
Cardiovascular Disease
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease. The study is an open-label, single dose study involving 6 healthy male subjects.
- Trial name
- NCT03948451
- Testing
- [14C]AZD5718 Oral Suspension
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
HIV Infections
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects.
- Trial name
- NCT02206711
- Testing
- BMS-955176
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
OIC
TD-1211 IV/Oral Mass Balance Study
The purpose of this study is to determine TD-1211 is processed by the body.
- Trial name
- NCT01702194
- Testing
- TD-1211 IV [C14], TD-1211 PO [C14]
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics