NCT04488900

Brief Summary

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

July 22, 2020

Last Update Submit

February 13, 2024

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability including treatment-emergent AE and treatment-emergent SAE

    28 days post the final dose

Secondary Outcomes (5)

  • Maximum plasma CKD-508 concentrations after dosing

    28 days post the final dose

  • Time of maximum plasma CKD-508 concentrations after dosing

    28 days post the final dose

  • Changes from baseline in plasma CKD-508 concentrations in time after dosing

    28 days post the final dose

  • Changes from baseline in CETP activity after dosing

    28 days post the final dose

  • Changes from baseline in lipid parameters after dosing

    14 days post the final dose

Study Arms (8)

Part 1. CKD-508 Capsule in Single Dose

EXPERIMENTAL

Single dose of CKD-508 capsules

Drug: CKD-508 Capsule

Part 1. Placebo Capsule in Single Dose

PLACEBO COMPARATOR

Single dose of Placebo capsules

Drug: Placebo Capsule

Part 2. CKD-508 Tablet in Single Dose

EXPERIMENTAL

Single dose of CKD-508 tablets for biocompartibility

Drug: CKD-508 Tablet

Part 2. Placebo Tablet in Single Dose

PLACEBO COMPARATOR

Single dose of Placebo tablets for biocompartibility

Drug: Placebo Tablet

Part 3. CKD-508 Tablet in Single Dose

EXPERIMENTAL

Single dose of CKD-508 tablets for food effect

Drug: CKD-508 Tablet

Part 3. Placebo Tablet in Single Dose

PLACEBO COMPARATOR

Single dose of Placebo tablets for food effect

Drug: Placebo Tablet

Part 4. CKD-508 Tablet in Multiple Dose

EXPERIMENTAL

Multiple dose of CKD-508 tablets

Drug: CKD-508 Tablet

Part 4. Placebo Tablet in Multiple Dose

PLACEBO COMPARATOR

Multiple dose of placebo tablets

Drug: Placebo Tablet

Interventions

CKD-508 CapsuleDRUG

Investigational drug

Part 1. CKD-508 Capsule in Single Dose
Placebo CapsuleDRUG

Placebo

Part 1. Placebo Capsule in Single Dose
CKD-508 TabletDRUG

Investigational drug

Part 2. CKD-508 Tablet in Single DosePart 3. CKD-508 Tablet in Single DosePart 4. CKD-508 Tablet in Multiple Dose
Placebo TabletDRUG

Placebo

Part 2. Placebo Tablet in Single DosePart 3. Placebo Tablet in Single DosePart 4. Placebo Tablet in Multiple Dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
  • Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
  • Females of non-childbearing potential (surgically sterile \[hysterectomy or oophorectomy\] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
  • Males must be unable to procreate (defined as surgically sterile \[i.e., had a vasectomy ≥6 months prior to screening\]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
  • Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).

You may not qualify if:

  • Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
  • Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
  • Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
  • Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 28, 2020

Study Start

July 6, 2020

Primary Completion

July 2, 2023

Study Completion

July 2, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

GB(1)