A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

Healthy Clinical Trial

Official title:

A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660890
• Other study ID #: ALXN2050-HV-107
• Status: Completed
• Phase: Phase 1
• Start date: December 12, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: November 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.

Description:

Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.

2. No clinically significant history or presence of ECG abnormalities at screening.

3. Female participants must be of non-childbearing potential and need not employ a method of contraception.

4. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.

2. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.

3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.

4. History or presence of clinically significant seizures, head injury, or head trauma.

5. History of procedures that could alter absorption or excretion of orally administered drugs.

6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.

7. History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.

8. Body temperature = 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.

9. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.

10. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2050
ALXN2050 will be administered orally twice daily as powder-in-capsule.
• ALXN2050-matching Placebo
ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
• Moxifloxacin
Moxifloxacin will be administered as a single oral dose.
• Moxifloxacin-matching Placebo
Moxifloxacin-matching placebo will be administered as a single oral dose.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050	Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.	Pre-dose through 24 hours post-dose
Secondary	Change From Baseline PR Interval (dPR) For ALXN2050	Twelve-lead ECGs will be extracted from continuous (Holter) recordings.	Pre-dose through 24 hours post-dose
Secondary	ddQTc For Moxifloxacin	Twelve-lead ECGs will be extracted from continuous (Holter) recordings.	Pre-dose through 24 hours post-dose
Secondary	Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050		Pre-dose through 24 hours post-dose
Secondary	Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050		Up to 24 hours postdose
Secondary	Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050		Pre-dose through 24 hours post-dose
Secondary	Incidence Of Treatment-emergent Adverse Events		Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration)