Safety and Pharmacokinetics of VT-1598

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of VT-1598 in Healthy Adult Subjects

ClinicalTrials.gov ID

NCT04208321

Acronym / sponsor ID

17-0087

Conditions

Coccidioidomycosis

Keywords

Adults, Healthy, Pharmacokinetics, Phase 1, Safety, Single Oral Doses, Tolerability, VT-1598

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

48 participants (actual)

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health

Study start

29 Sep 2020 (actual)

Primary completion

27 Dec 2021 (actual)

Study completion

27 Dec 2021 (actual)

First posted

23 Dec 2019 (actual)

Results

Posted 11 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Sequential

Masking

Double blind (participant, investigator)

Number of arms

6

Who may qualify

Ages

18 to 45 years

Sex

All

Healthy volunteers

Accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Unsolicited Adverse Events

   Time frame: Day 1 through Day 21

   Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.

2. Number of Participants With Abnormal Chemistry Laboratory Toxicity Results

   Time frame: Baseline (Day -1) through Day 21

   Laboratory parameters and associated thresholds include albumin <=3.4 g/dL, glucose <= 69 mg/dL or >=106 mg/dL, blood urea nitrogen (BUN) >= 21 mg/dL, potassium >=5.2 mEq/L or <=3.4 mEq/L, calcium < 8.7 mg/dL or >=10.3 mg/dL, sodium <=132 mEq/L or >=144 mEq/L, total protein <=5.9 g/dL, creatinine >=1.3 mg/dL (male) or >= 1.0 mg/dL (female), creatine phosphokinase >= 308 U/L (male) or >=192 U/L (female), phosphorus <=2.4 mg/dL, alkaline phosphatase >= 130 IU/L (males) or >= 105 IU/L (female), aspartate aminotransferase >= 39.9 U/L (male) or >= 31.9 U/L (female), alanine aminotransferase >=40.9 U/L (male) or >= 32.9 U/L (female), total bilirubin >=1.2 mg/dL, direct bilirubin >=0.2 mg/dL, magnesium <=1.6 mg/dL, and serum cortisol <= 4 ug/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

3. Number of Participants With Abnormal Hematology Laboratory Toxicity Results

   Time frame: Baseline (Day -1) through Day 21

   Laboratory parameters and associated thresholds for adverse events include hemoglobin <= 12.2 g/dL (male) or <= 10.8 g/dL (female), hematocrit <= 36.1 % (male) or <= 32.6 % (female), lymphocyte count <= 799 cell/mm3, neutrophil count <= 1,299 cell/mm3 (African Americans) or <= 1,699 cell/mm3 (all others), monocyte count >= 1001 cell/mm3, eosinophil count >= 871 cell/mm3, basophil count >= 101 cell/mm3, platelet count <= 150 x 10^3/mm3, red blood cell (RBC) count <= 4.1 x 10^6/uL (male) or <= 3.7 x 10^6/uL (female), and white blood cell (WBC) count >= 9,001 cell/mm3 or <= 2,499 cell/mm3 (African American Males) or >= 11,001 cell/mm3 or <= 2,499 cell/mm3 (African American Females) or >= 10,001 cell/mm3 or <= 3,999 cell/mm3 (all others). If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.

4. Number of Participants With Abnormal Coagulation Laboratory Toxicity Results

   Time frame: Baseline (Day -1) through Day 21

   Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT >= 11.6 s, PTT >= 30.1 s, INR >= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

5. Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results

   Time frame: Baseline (Day -1) through Day 21

   The only graded urinalysis laboratory parameter was red blood cells (RBC) by complete urinalysis. The threshold for adverse events was considered as >=3. If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.

6. Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results

   Time frame: Day 1 through Day 21

   Each participant is only counted once per toxicity grade for the worst severity recorded. The only ECG parameter graded was QTcF interval with a threshold of >= 30 msec. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.

7. Number of Participants With Abnormal Vital Signs

   Time frame: Baseline (Day -1) through Day 21

   Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP >= 141 mmHg or <= 89 mmHg, diastolic BP >= 91 mmHg, pulse <= 54 bpm (baseline > 60 bpm) or <=50 (baseline <= 60 bpm) or >= 101 bpm, respiratory rate >= 17 breaths per minute, and temperature >= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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