Grayslake

Researchers are conducting a Phase 1 study to evaluate the safety and how the body processes two oral drugs, ABBV-722 and Upadacitinib, in healthy adult volunteers aged 18 to 65 years. The study focuses on understanding the pharmacokinetic interaction between these medications when taken together in multiple doses. Participants must be generally healthy based on medical history, physical exams, vital signs, lab tests, and ECG results. The study involves administering multiple oral doses of ABBV-722 and Upadacitinib to the participants. The pharmacokinetics of both drugs will be measured during different study periods, including up to Day 6 in Period 2, up to Day 7 in Period 1, and up to Day 17 in Period 3. Dosing schedules and detailed plasma concentration measurements will help assess how the drugs interact when taken together. Participants will undergo various assessments including blood tests to measure drug concentrations at different times, monitoring for adverse events over approximately 91 days, and safety evaluations throughout the study. Researchers will track maximum and trough drug levels, time to maximum concentration, and the area under the drug concentration curve to understand drug behavior in the body. The total study duration includes these multiple periods of dosing and follow-up for safety.

This research aims to evaluate how repeated doses of ABBV-722 affect the single-dose drug levels of ethinyl estradiol and levonorgestrel in healthy adult women. The study focuses on understanding the pharmacokinetics, which describe how these drugs move through the body, including their concentration and elimination over time. It is a Phase 1 trial involving healthy female volunteers aged 18 to 65 years. Participants will receive oral doses of ABBV-722 along with a combined oral contraceptive containing ethinyl estradiol and levonorgestrel. The study measures drug levels at specific times, including up to day 5 in the first period and between days 14 to 21 in the second period. The investigation monitors how the body absorbs and breaks down these medications when given together. During the study, participants will undergo assessments such as blood sampling to measure drug concentrations, vital signs, laboratory tests, medical history reviews, physical exams, and ECGs. Researchers will track adverse events for up to approximately 82 days to monitor safety. The primary outcomes include plasma concentration measures of both drugs and any side effects experienced throughout the study.

The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin

This research aims to evaluate the safety, tolerability, pharmacokinetics, and immune response to ABBV-243 given as single ascending doses either by intravenous (IV) infusion or subcutaneous (SC) injection in healthy adults. The study includes a first part involving healthy adult participants and a second part focusing on healthy Asian adult volunteers, including Japanese and Han Chinese individuals. This phase 1 trial investigates how the body processes ABBV-243 and monitors any side effects that may arise. Participants will receive ABBV-243 or a placebo either as an IV infusion or SC injection in varying doses. The study has two parts: Part 1 with escalating single doses in healthy adults, and Part 2 with a single IV dose in healthy Asian adults. The treatments are administered in a controlled setting, and participants are monitored closely throughout the study period. During the study, participants will attend regular visits at a hospital or clinic for medical assessments, blood tests, and questionnaires to check for side effects and treatment effects. Researchers will measure drug levels in the blood over time, including peak concentration and elimination rates, and monitor immune responses such as anti-drug antibodies. Safety and tolerability will be assessed up to 204 days after dosing to understand how participants respond to ABBV-243 over time.

Researchers are evaluating the safety, side effects, body weight changes, and how the drug ABBV-295 moves through the body in adult participants with obesity. This Phase 1b study compares ABBV-295 given as subcutaneous injections to a matching placebo to better understand its effects and tolerability in this population. Participants will receive multiple doses of ABBV-295 or placebo through injections under the skin. The study monitors how the drug is absorbed, distributed, metabolized, and eliminated from the body over approximately 145 days. During the study, participants will have their vital signs, electrocardiograms, laboratory tests, and body weight measured regularly. Researchers will track any adverse events, changes in clinical tests, and the body's immune response to the drug. Pharmacokinetic parameters such as plasma drug concentrations will be assessed to understand drug behavior over the treatment period.

Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, and how the drug ABBV-722 moves through the body after oral dosing in healthy adults. The study includes single and multiple ascending doses in adult participants, including a group of healthy adult Asian participants. The focus is on understanding the body's response to ABBV-722 and monitoring any adverse effects. Participants will receive either ABBV-722 oral capsules or placebo capsules. The study involves different parts: Parts 1 and 2 include single and multiple ascending doses, and Part 3 involves single doses in healthy adult Asian subjects. The dosing schedules and amounts vary to assess the drug's pharmacokinetics and safety across different groups. During the study, participants will undergo safety evaluations up to day 44, including monitoring for adverse events. Blood samples will be taken to measure drug concentrations and pharmacokinetic parameters like maximum plasma concentration, time to maximum concentration, and drug elimination rates up to day 21. Additional assessments include laboratory tests, physical exams, vital signs, and ECGs. The total participation duration and follow-up procedures help ensure thorough safety monitoring.

Researchers are evaluating the safety, tolerability, and how the body processes oral doses of ABBV-1042 in healthy adult volunteers. This phase 1, double-blind, placebo-controlled study aims to assess adverse events and pharmacokinetics of single ascending doses of ABBV-1042, providing initial human data on this drug. Participants will receive either the oral solution of ABBV-1042 or a placebo in escalating doses. The study monitors how the drug moves through the body, including measurements like maximum plasma concentration and elimination half-life. The treatment period and monitoring last up to approximately 3 days, with adverse events tracked for up to about 32 days. During the study, participants will undergo medical history reviews, physical exams, vital sign checks, ECGs, laboratory tests, and assessments using the Columbia-Suicide Severity Rating Scale. Researchers will monitor changes from baseline in these parameters and collect blood samples to analyze drug levels. Safety and tolerability will be closely observed throughout the study period.

Researchers are evaluating how oral emraclidine is processed in the bodies of healthy elderly adults and assessing its safety and tolerability. This Phase 1 study focuses on participants aged 65 to 85 years who are in general good health. The goal is to understand how the drug moves through the body and to monitor any adverse effects that may occur during the study period. Participants receive multiple ascending doses of oral emraclidine or a matching placebo in a randomized, placebo-controlled design. The study examines the pharmacokinetics of emraclidine, including measures such as plasma concentration and metabolite ratios, during up to approximately 20 days of dosing. The study also tracks adverse events and other safety parameters related to the drug’s effects. Throughout the study, participants undergo medical history reviews, physical exams, vital sign monitoring, laboratory tests, ECGs, and assessments of movement and mental health scales. Researchers measure changes from baseline in these parameters and analyze drug concentration levels in the blood. The study period lasts up to about 50 days to capture adverse events and other safety data, helping to evaluate the drug’s overall safety and tolerability in this population.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.