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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Ed Burgard, PhD
- Telefonnummer: 919-371-8138
- E-post: eburgard@dignifytherapeutics.com
Studer Kontakt Backup
- Navn: Karl Thor, PhD
- Telefonnummer: 919-371-8138
- E-post: kthor@dignifytherapeutics.com
Studiesteder
-
-
Texas
-
Austin, Texas, Forente stater, 78744
- Rekruttering
- Thermo Fisher
-
Ta kontakt med:
- Katherine Sides, MD
- Telefonnummer: 512-447-2985
- E-post: CRGstudyinfo.sm@thermofisher.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
|
Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events
Tidsramme: Up to seven days
|
Absolute values and change from baseline |
Up to seven days
|
|
Number of participants with abnormal lab test results
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to seven days
|
Absolute values and change from baseline ECG intervals |
Up to seven days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetic Cmax
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 hours post-dose
|
24 hours post-dose
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- DTI-117-101
Legemiddel- og utstyrsinformasjon, studiedokumenter
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