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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Ed Burgard, PhD
- 전화번호: 919-371-8138
- 이메일: eburgard@dignifytherapeutics.com
연구 연락처 백업
- 이름: Karl Thor, PhD
- 전화번호: 919-371-8138
- 이메일: kthor@dignifytherapeutics.com
연구 장소
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Texas
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Austin, Texas, 미국, 78744
- 모병
- Thermo Fisher
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연락하다:
- Katherine Sides, MD
- 전화번호: 512-447-2985
- 이메일: CRGstudyinfo.sm@thermofisher.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
실험적: 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. |
|
실험적: 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. |
|
실험적: 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. |
|
실험적: 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. |
|
위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with adverse events
기간: Up to seven days
|
Absolute values and change from baseline |
Up to seven days
|
|
Number of participants with abnormal lab test results
기간: 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
기간: 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
기간: Up to seven days
|
Absolute values and change from baseline ECG intervals |
Up to seven days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetic Cmax
기간: 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
기간: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
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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
|
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Pharmacokinetic half-life (t1/2)
기간: 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
|
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Pharmacokinetic AUClast
기간: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
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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
|
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Pharmacokinetic AUCinf
기간: 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
기간: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
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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
|
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Pharmacokinetic VzF
기간: 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
|
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Time to urination and defecation
기간: 24 hours post-dose
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24 hours post-dose
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DTI-117-101
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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