Clinical trials: Phase 1
Non-alcoholic Fatty Liver Disease, Obesity
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease…
- Trial name
- NCT05970640
- Testing
- BI 3006337
- Where
- 12 sites in United States
- Volunteers
- 64 people
- Sponsor
- Boehringer Ingelheim
Breast Neoplasm, Breast Neoplasm, Male
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and…
- Conditions
- Breast Neoplasm, Breast Neoplasm, Male, Triple Negative Breast Cancer
- Trial name
- NCT02950259
- Testing
- Cyclophosphamide, Indomethacin, Omeprazole
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Providence Health & Services
Colorectal Cancer, Colorectal Tumors
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
- Conditions
- Colorectal Cancer, Colorectal Tumors, Colorectal Carcinoma, Colorectal Neoplasm
- Trial name
- CheckMate 9N9 (NCT03377361)
- Testing
- Nivolumab, Trametinib, Ipilimumab
- Where
- 47 sites in United States, Argentina and 8 more
- Volunteers
- 325 people
- Sponsor
- Bristol-Myers Squibb
Advanced Malignant Solid Neoplasm, Metastatic Carcinoma in the Liver
BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers
This phase I/II trial studies the side effects and best dose of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 (BMS-986156) when given together with ipilimumab and…
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Carcinoma in the Liver, Metastatic Carcinoma in the Lung, Metastatic Malignant Neoplasm in the Thoracic Cavity
- Trial name
- NCT04021043
- Testing
- Anti-GITR Agonistic Monoclonal Antibody BMS-986156, Ipilimumab, Nivolumab
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- M.D. Anderson Cancer Center
Peripheral Edema
Wireless TENS for Peripheral Edema (Lower Limb Swelling)
This study is single center, subject will receive a wireless TENS device. All subjects will be allowed to keep the commercially-available device for use after the study.
- Trial name
- NCT04680533
- Testing
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Rochester
Healthy
A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.
- Trial name
- NCT06494761
- Testing
- zongertinib, midazolam, omeprazole
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV-1-infection on Healthy Volunteers
The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role…
- Trial name
- DTG Clamp (NCT04771754)
- Testing
- Dolutegravir
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
Kita-kyushu Lung Cancer Antigen 1, Human
T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
Background: Researchers have found a new way to treat cancer using T cell therapy. The therapy used in this study is T Cell Receptor (TCR) Gene Therapy Targeting Kita-Kyushu Lung Cancer Antigen-1 (KK-LC-1), a cancer germline…
- Trial name
- NCT05035407
- Testing
- IL-2 (Aldesleukin), Cyclophosphamide, KK-LC-1 TCR
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
Myelodysplastic Syndromes
Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes
Background: Myelodysplastic syndromes (MDS) are diseases that affect the bone marrow. They can inhibit the blood formation process and reduce blood cell counts. High-risk MDS can lead to leukemia.
- Trial name
- NCT05918055
- Testing
- KPT-8602, Inqovi, Bone marrow aspirate
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
Cystic Fibrosis
Growth Hormone Therapy for Wasting in Cystic Fibrosis
Our hypothesis is that Growth Hormone (GH) will not only target the peripheral tissue to stimulate weight and muscle growth which will maximize nutritional potential and improve overall quality of life.
- Trial name
- NCT00803179
- Testing
- Nutropin AQ
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Massachusetts, Worcester
Healthy
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
The main objective of this trial is to investigate the induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.
- Trial name
- NCT06070610
- Testing
- BI 1015550, Nintedanib, Pirfenidone
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food
The main objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.
- Trial name
- NCT06415045
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men
The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.
- Trial name
- NCT06139302
- Testing
- Nerandomilast
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood
The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.
- Trial name
- NCT05550636
- Testing
- BI 1015550, midazolam
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.
- Trial name
- NCT06393127
- Testing
- Nerandomilast
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.
- Trial name
- NCT06408870
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single…
- Trial name
- NCT04771286
- Testing
- BI 1015550 (C-14)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Breast Cancer
A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers
This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab.
- Conditions
- Advanced Head and Neck Squamous Cell Carcinoma, Advanced Breast Cancer, Advanced Melanoma
- Trial name
- Catalyst (NCT05383170)
- Testing
- CyPep-1, Pembrolizumab 25 MG/ML [KEYTRUDA®]
- Where
- 25 sites in United States, France and 3 more
- Volunteers
- 6 people
- Sponsor
- Cytovation AS
Healthy
A Study in Healthy Men to Test How BI 1015550 is Taken up and Handled by the Body
This trial is intended to examine the absolute oral bioavailability of BI 1015550 as tablet formulation for oral administration, using an intravenous microtracer approach with [14C]-labelled BI 1015550.
- Trial name
- NCT05707403
- Testing
- BI 1015550, BI 1015550 mixed with [C-14]-BI 1015550
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood
The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e.
- Trial name
- NCT03403439
- Testing
- BI 1015550, itraconazole
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim