Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Caps… (NCT07222878) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042
United States8 participantsStarted 2025-09-29
Plain-language summary
A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
Who can participate
Age range19 Years – 65 Years
SexALL
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Inclusion Criteria:
* Males and females between 19 and 65 years of age, inclusive.
* Body mass index (BMI) of 18 to 35 kg/m2, inclusive, using the following formula: weight (kg)/\[height (m)\]
* A minimum body weight of 50 kg for males and 45 kg for females.
* All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
* Females must be of non-child-bearing potential.
* Male participants with female partners of reproductive potential must agree to protocol specifications.
Exclusion Criteria:
* Clinically significant acute illness within 2 weeks prior to Day -1.
* Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
* Presence of an active malignancy or a malignancy of any type within the past 5 years, other than squamous cell or basal cell carcinoma of the skin.
* Clinically significant acute or chronic infection or known inflammatory condition.
* Personal or family history of long QT syndrome.
* History or evidence of adverse symptoms associated with phlebotomy or blood donation
* History of clinically significant orthostatic hypotension or any vasovagal syncope.
* Plans for surgery or other medical procedures during the study.
* Clinically significant past or current medical or surgical history that could inte…
What they're measuring
1
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Timeframe: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
2
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Timeframe: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
3
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Timeframe: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
4
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Timeframe: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
5
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Timeframe: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
6
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.