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A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects

NCT06277492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-12-01

No results posted yet for this study

Summary

The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years).

Conditions

  • Healthy Subjects

Interventions

DRUG

Single dose SUL-238

PART 2: SUL-238 single dose for pharmacokinetics

DRUG

Multiple ascending doses SUL-238

PART 3: SUL-238 multiple ascending doses

DRUG

Multiple doses Placebo

PART 3: Placebo multiple doses

DRUG

2000 mg SUL-238 single dose for pharmacokinetics (food effect)

PART 2B: 2000 mg single dose of SUL-238

DRUG

Single dose placebo (food effect)

PART 2B: Placebo single dose

DRUG

Single ascending doses SUL-238

PART 1: SUL-238 single ascending doses

DRUG

Single dose Placebo

PART 1: Placebo single dose

Sponsors & Collaborators

  • Sulfateq B.V.

    collaborator UNKNOWN

  • GEN İlaç ve Sağlık Ürünleri A.Ş.

    lead INDUSTRY

Principal Investigators

  • Zafer Sezer, MD · Department of Pharmacology, Faculty of Medicine, Erciyes University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2025-07-11
Completion
2025-11-27

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06277492 on ClinicalTrials.gov