SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476107
• Other study ID #: AMT-126-001
• Secondary ID: 2020-005779-11
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2021
• Est. completion date: March 26, 2022

Study information

• Verified date: July 2022
• Source: Applied Molecular Transport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Description:

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

PART 1 & 2 (Healthy Volunteers)

Inclusion Criteria:

• Healthy male subjects and female subjects of NOCBP.

• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.

• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.

• Contraception requirements for male & female subjects.

Exclusion Criteria:

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.

• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).

• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.

• Evidence of current SARS-CoV-2 or COVID infection.

• Women of child-bearing potential.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AMT-126
Single or daily dosing at doses A, B, C, D, E, F; G, H, and I
• Placebo
Single or daily dosing at doses A, B, C, D, E, F; G,H, and I

Other:
• Radioactive Tablet (Part 2 Only)
Single dose in two periods in Part 2 (optional)

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Applied Molecular Transport

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent adverse events (safety and tolerability)	Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0	5 days
Primary	To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)	Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)	5 days
Secondary	To assess pharmacokinetics of AMT-126 in healthy volunteers	Assess PK parameters (i.e. Cmax) as applicable for AMT-126	5 days