Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05025397
Other study ID # TAK-925-1019
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 28, 2021
Est. completion date March 8, 2022

Study information

Verified date May 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of the study are: - to assess the safety profile of danavorexton when it is administered with anesthetics. - to learn what effect danavorexton has on anesthetized adults. On Day 1, participants will receive a single intravenous (IV) infusion of danavorexton or a placebo after participants have been anesthetized for about 40 minutes. Clinic doctors will arrange a follow-up visit by phone or video on Day 7.


Description:

The drug being tested in this study is called danavorexton or TAK-925. Danavorexton is being tested to evaluate safety, tolerability, PK, and pharmacodynamics (PD) in healthy participants. The study will enroll approximately 28 participants. This study consists of 4 cohorts: Cohorts A1, A2, A3 and P (healthy participants aged 18 to 55 years). In each of the 4 cohorts, participants will be randomly assigned (by chance) to receive danavorexton or danavorexton placebo-matching -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): - Cohort A1: Danavorexton Low Dose - Cohort A2: Danavorexton Middle Dose - Cohort A3: Danavorexton High Dose - Cohort P: Danavorexton TBD Additional optional cohorts may be added to the study based on the outcomes from the mandatory cohorts described above. This trial will be conducted in the United States. The overall time to participate in this study is 37 days including screening period, residential period, and safety follow up period. A follow-up visit by phone or video will be conducted on Day 7.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date March 8, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Current non-smoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before the administration of the study drug. 2. Has regular sleep-wake habits (example, routinely spends 6.5 to 9 hours in bed nightly). 3. Aged 18 to 55 years, inclusive, at the screening visit. 4. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m^2) at the screening visit. 5. Must be American Society of Anesthesiologists (ASA) Classification I with a Mallampati score less than (<) III, and judged to be in good health based on results of safety laboratory tests (biochemistry, hematology, and urinalysis testing) performed at the screening visit and on medical history, physical examination, vital-sign measurements, and 12-lead electrocardiogram (ECG) performed at screening and Study Day 1 visits. 6. Not expected to have difficulty with the use of an laryngeal mask airway (LMA) as determined by the anesthesiologist or site staff. Exclusion Criteria: 1. Received immunotherapy within the past year. 2. Has a history or family history of malignant hyperthermia or are known or suspected to have an allergy to inhalational anesthetics, propofol, neuromuscular blocking agents and/or other drugs used during general anesthesia. 3. Has facial hair that could interfere with the seal of a facemask per investigator or site staff and is unwilling to shave it off before check-in. 4. Has undergone major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit. 5. Has a risk of suicide according to endorsement of Item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening/baseline visit or have made a suicide attempt in the previous 6 months. 6. Has a positive alcohol or drug screen at screening or Day 1 or has a history of alcohol consumption exceeding 2 standard drinks per day on average within the 12 months before screening. Participants who test positive for cannabis will be excluded. 7. Has caffeine consumption of more than 400 milligram per day (mg/day) for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 milligram [mg] of caffeine). 8. Has a screening ECG with a QT interval with Fridericia correction method (QTcF) greater than (>) 450 millisecond (ms) (men) or >470 ms (women).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Danavorexton
Danavorexton intravenous infusion.
Danavorexton Placebo
Danavorexton placebo-matching intravenous infusion.
Propofol
Propofol intravenous bolus.
Sevoflurane
Sevoflurane inhalation.
Propofol
Propofol intravenous infusion.

Locations

Country Name City State
United States Endeavor Clinical Trials San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE) Up to Day 7
Secondary Ceoi: Observed Plasma Concentration at the end of Infusion for Danavorexton Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
Secondary AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Danavorexton Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
Secondary AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Danavorexton Day 1: Pre-anesthesia, pre-infusion and at multiple timepoints (up to 24 hours) post-infusion
See also
  Status Clinical Trial Phase
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1