A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With an Open Label (Single Dose) Food Effect Panel
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Gates MRI
- Phone Number: +1-857-702-2108
- Email: clinical.trials@gatesmri.org
Study Locations
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-
Nebraska
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Lincoln, Nebraska, United States, 68502
- Celerion
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial.
- Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure.
- Can complete all Screening period evaluations and stay in the clinical research facility for the duration of the inpatient periods of the trial.
- Has Body Mass Index (BMI) between 18 and 32 kilograms per meter square (kg/m2), inclusive, and body weight not less than 50 kg at Screening.
Has resting vital signs within the following ranges at Screening and Day -1:
- Systolic blood pressure (SBP) >= 100 millimeters of Mercury (mmHg) and <= 140 mmHg
- Diastolic blood pressure (DBP) >= 60 mmHg and <= 90 mmHg
- Heart rate between 50 and 100 beats per minute (bpm)
If individual's assigned sex at birth is female, they must have negative urine and serum pregnancy tests at Screening, and be of non-childbearing potential based on either of the following:
- Is post-menopausal defined as amenorrhea for at least 12 months in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory-defined postmenopausal range, or,
- Reports being surgically sterilized (ie, tubal ligation, hysterectomy, bilateral oophorectomy/salpingectomy), and provides written documentation [(ie, medical record(s)], where feasible, to document such procedure(s) to the Principal Investigator. The site must make documented attempts to obtain medical records. If records cannot be retrieved, a participant may be enrolled at the Principal Investigator's discretion.
Exclusion Criteria:
- Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator.
- Has history of or has clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, controlled or uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- Had an active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or melanoma will be exclusionary.
- Has history of any drug abuse within 1 year prior to Screening or has used any hard drugs (such as cocaine, phencyclidine [PCP], natural and synthetic opiates, and amphetamine derivatives) within 1 year prior to Screening. Individuals that have taken an opioid or amphetamine medication within the previous year prior to Screening that was prescribed by a healthcare provider will not be excluded unless they are currently taking the medication at the time of Screening.
- Had any surgical or medical condition or history that, in the opinion of the Investigator, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass, sleeve, banding surgery, or gastric or duodenal ulcers.
Additional inclusion/exclusion criteria are defined in the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Participants in Part 1 (cohorts 1-5 and cohort 7) and Part 2 will receive placebos matched to TBD11
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Placebo will be administered orally.
|
|
Experimental: TBD11
In Part 1 double-blind phase of the trial (SAD), cohorts 1 to 5 and cohort 7 will receive doses of TBD11; 8 participants in each cohort will be randomized (6:2) to receive TBD11 or placebo. The FE component of Part 1 (cohort 6) is open-label and 12 participants will receive TBD11 to evaluate the food effect. In Part 2, double blind phase of the trial, MAD, 48 participants will be randomized (3:1) to receive TBD11 or placebo in Cohorts 1-3. In Part 2 (Cohort 4), all participants will receive open-label TBD11 |
Placebo will be administered orally.
TBD11 will be administered orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) after administration of single doses or multiple doses in healthy adult participants
Time Frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
|
|
Number of participants with clinically significant changes from Baseline in clinical laboratory values
Time Frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
Blood samples will be collected for the analysis of clinical laboratory measures including clinical chemistry, hematology, coagulation, and urinalysis.
|
Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
|
Number of participants with clinically significant changes from Baseline in vital signs
Time Frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
|
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Number of participants with clinically significant changes from Baseline in Electrocardiogram (ECG) parameters
Time Frame: Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
ECG parameters include heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected by Fridericia's formula [QTcF].
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Part (Pt.) 1 (Cohorts 1-5, 7):Day 1-7; Pt. 1 (Cohort 6, Periods [Pds.] 1-3):Day 1 through the washout of each respective Pd.; Pt. 2 (Cohorts 1-3):Day 1-19; Pt. 2 (Cohort 4): Pd.1: Day 1 through last day of washout; Pd.2: Day 1 through last day of washout
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part 1: Maximum plasma drug concentration (Cmax) of TBD11 in treated participants
Time Frame: Day 1
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Blood samples are collected at indicated time points for pharmacokinetic (PK) analysis of TBD11.
PK parameters are analyzed using standard non-compartmental analysis.
|
Day 1
|
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Part 1: Area under the concentration-time curve calculated to last quantifiable observed sample (AUClast) of TBD11 in treated participants
Time Frame: Day 1 through Day 7
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Day 1 through Day 7
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Part 1: Terminal elimination half-life (t1/2) of TBD11 in treated participants
Time Frame: Day 1 through Day 7
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Day 1 through Day 7
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|
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Part 1: Time to maximal concentration (Tmax) of TBD11 in treated participants
Time Frame: Day 1
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Day 1
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|
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Part 2: Cmax of TBD11 in treated participants
Time Frame: Day 1 and Day 14
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Day 1 and Day 14
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|
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Part 2: Tmax of TBD11 in treated participants
Time Frame: Day 1 and Day 14
|
Day 1 and Day 14
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|
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Part 2: Minimum plasma drug concentration (Cmin) of TBD11 in treated participants
Time Frame: Day 14
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Day 14
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|
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Part 2: Accumulation ratio (area under plasma concentration-time curve over dosing interval [AUCtau] / AUC0-24) of TBD11 in treated participants
Time Frame: Day 14
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Day 14
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Part 2: Area Under the concentration time curve from Zero to 24 hours (AUC 0-24) of TBD11 in treated participants
Time Frame: Day 1
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Day 1
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Part 2: AUC last of TBD11 in treated participants
Time Frame: Day 1 and Day 14
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Day 1 and Day 14
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Part 2, Cohort 4: Geometric mean ratio (GMR) Cmax,capsules / Cmax,tablets in treated participants
Time Frame: Day 1 through last day of washout of the treatment period
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Day 1 through last day of washout of the treatment period
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Part 2: Cohort 4: GMR AUC (0-infinity) capsules / AUC(0-inf) tablets
Time Frame: Day 1 through last day of washout of the treatment period
|
Day 1 through last day of washout of the treatment period
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- Gates MRI-TBD11-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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