A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) Doses of DTI-117 in Healthy Participants.
This is a single ascending dose, double-blind, placebo-controlled, randomized evaluation of the safety, tolerability, and pharmacokinetics of DTI-117 in healthy volunteers. There will be up to five cohorts of 8 healthy participants each cohort.
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Ed Burgard, PhD
- Numero di telefono: 919-371-8138
- Email: eburgard@dignifytherapeutics.com
Backup dei contatti dello studio
- Nome: Karl Thor, PhD
- Numero di telefono: 919-371-8138
- Email: kthor@dignifytherapeutics.com
Luoghi di studio
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Texas
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Austin, Texas, Stati Uniti, 78744
- Reclutamento
- Thermo Fisher
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Contatto:
- Katherine Sides, MD
- Numero di telefono: 512-447-2985
- Email: CRGstudyinfo.sm@thermofisher.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provide written informed consent to participate.
- Adult male and female healthy volunteers between 18 to 65 years of age, inclusive.
- General good health, with no clinically relevant abnormalities as determined by the medical history, physical exam, ECG, and clinical laboratory results.
- Screening body weight between 45 and 100 kg, inclusive, with body mass index (BMI) ≤32 kg/m2.
Exclusion Criteria:
- Gastrointestinal or urological surgery in the previous 6 months.
- Presence of any clinically significant infectious, cardiac, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, in the opinion of the investigator.
- History of colitis.
- Current chronic intermittent constipation requiring medication more than twice per month.
- Use of any investigational drug within 30 days of Screening or 5 drug half-lives, whichever is longer.
- Individuals not willing or unable to tolerate blood draws or individuals with poor venous access.
- Presence or history of any condition that, in the opinion of the Investigator, might reasonably jeopardize the safety of the participant, the ability to collect study data, or the validity of the study results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 0.03 mg/kg DTI-117
Participants receive a single IM dose of DTI-117 0.03 mg/kg. |
Single intramuscular injection of DTI-117 at the assigned dose level. |
|
Sperimentale: 0.05 mg/kg DTI-117
Participants receive a single IM dose of DTI-117 0.05 mg/kg. |
Single intramuscular injection of DTI-117 at the assigned dose level. |
|
Sperimentale: 0.1 mg/kg DTI-117
Participants receive a single IM dose of DTI-117 0.1 mg/kg. |
Single intramuscular injection of DTI-117 at the assigned dose level. |
|
Sperimentale: 0.2 mg/kg DTI-117
Participants receive a single IM dose of DTI-117 0.2 mg/kg. |
Single intramuscular injection of DTI-117 at the assigned dose level. |
|
Sperimentale: 0.3 mg/kg DTI-117
Participants receive a single IM dose of DTI-117 0.3 mg/kg. |
Single intramuscular injection of DTI-117 at the assigned dose level. |
|
Comparatore placebo: Placebo
Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP. |
Single intramuscular injection of 0.9% Sodium Chloride Injection, USP. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with adverse events
Lasso di tempo: Up to seven days
|
Absolute values and change from baseline |
Up to seven days
|
|
Number of participants with abnormal lab test results
Lasso di tempo: Up to seven days
|
Absolute values and change from baseline for clinical chemistry and hematology |
Up to seven days
|
|
Number of participants with abnormal vital signs
Lasso di tempo: Up to seven days
|
Absolute values and change from baseline (oral body temperature, respiratory rate, blood pressure, and heart rate) |
Up to seven days
|
|
Number of participants with abnormal ECG
Lasso di tempo: Up to seven days
|
Absolute values and change from baseline ECG intervals |
Up to seven days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pharmacokinetic Cmax
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Maximum (peak) observed concentration of DTI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic Tmax
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Time to maximum observed concentrations of DTI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic half-life (t1/2)
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Time to terminal elimination half-life concentrations of DTI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic AUClast
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Area under the concentration-time curve from zero to the last concentration quantifiable for DTI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic AUCinf
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Area under the plasma concentration-time curve from time zero extrapolated to infinity for TI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic CL/F
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Apparent total plasma clearance after oral administration of TI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Pharmacokinetic VzF
Lasso di tempo: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
Apparent volume of distribution during terminal elimination phase after oral administration of DTI-117 |
Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
|
|
Time to urination and defecation
Lasso di tempo: 24 hours post-dose
|
24 hours post-dose
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- DTI-117-101
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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